Synchromed II
Published on May 24, 2017
No Description
MORE DECKS TO EXPLORE
PRESENTATION OUTLINE
Untitled Slide
Untitled Slide
1982 First human implant of SynchroMed pump (Medtronic).
1998 SynchroMed pump receives FDA approval (Medtronic).
2004 SynchroMed II pump receives FDA approval (Medtronic).
1999 SynchroMed EL was approved and was discontinued in 2007 as Synchro Med II gained acceptance.
1998 SynchroMed pump receives FDA approval (Medtronic).
2004 SynchroMed II pump receives FDA approval (Medtronic).
1999 SynchroMed EL was approved and was discontinued in 2007 as Synchro Med II gained acceptance.
The pump delivers prescribed drugs to the patient's body through cerebrospinal fluid.
The battery is expected to last up to 4 years.
Photo by tamahaji
SynchroMed pumps treat primary or metastatic cancer, chronic pain, and severe spasticity.
The SynchroMed pumps used in spasticity are often called Baclofen pumps.
Photo by Nina Matthews Photography
Types of Drugs used:
- Opioids
- Local anesthetics
- Baclofen
- Ziconotide
The pump can be programmed to deliver continuous, intermittent or complex circadian administrations.
Zincontide is used to treat chronic pain, it is a non narcotic.
Zincontide is used to treat chronic pain, it is a non narcotic.
Photo by srqpix
Placement
- Children - subfascially in one side of the abdomen, or intrathecally (spinal canal)
- Adult - in the back intrathecally (spinal canal)
- Adult - epidural
The placement of the device is determined by the type of medication being administered and the age of the patient.
The term Intrathecally is abbreviated as IT or IDD (Intrathecal Drug Delivery).
The pump is connected to a thin flexible catheter; both are implanted under the skin.
The term Intrathecally is abbreviated as IT or IDD (Intrathecal Drug Delivery).
The pump is connected to a thin flexible catheter; both are implanted under the skin.
Medtronic Recall
software problem, unintended delivery of drugs
On October 3, 2016 Medtronic initiated an update recall to communications issued on May 14, 2013. Medtronic made a software change to the Synchromed II application contained on the Model 8870 software application card. The change will correct the priming volume associated with the priming bolus function. They also updated the labeling related to the software change and priming bolus function.
Problems
- high rate of infusion
- reduced drug delivery
- overdose
- underdose
Patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences.
Complications
- Site Infection/Sepsis
- Explant/ Revision Surgery
- Kinked/ Blocked catheter
- Erosion/ Exposure
- Cellulitis
- Battery Depletion
- Alarm Malfunction
- Device flipping
Complication that may require surgery to correct: inflammatory mass, spinal cord damage.
Adverse Events: Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter
Adverse Events: Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter
Untitled Slide
Reason for Recall: The SynchroMed Implantable Infusion Pumps were being recalled because of the:
1. Unintended delivery of drugs during the priming bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus.
2. There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy.
3. The Sutureless Connector Intrathecal Catheter connector had been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump.
1. Unintended delivery of drugs during the priming bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus.
2. There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy.
3. The Sutureless Connector Intrathecal Catheter connector had been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump.
MAUDE AE's
- In 2016 over 1000 injuries reported.
- 2017 over 784 injuries reported.
- 90 deaths reported in last 2 years.
It appears that old entries as far back as 1998 have finally made it to this years MAUDE reporting. Those older reports were removed from the current tallies.
Photo by mac steve
As of July 5, 2016, there were 103 incidents of overinfusion reported among the more than 238,000 SynchroMed II pumps implanted since the device came to market.
Photo by HPUPhotogStudent
FDA Investigation
- In 2015 FDA enters a consent decree with Medtronic
- For repeatedly failing to correct violations
- Over/under infusion problems identified by the FDA in 2006
- 2006-2013, 5 inspections, 3 warning letters
Photo by joiseyshowaa
Noted FDA Violations
- Failure to document design changes.
- Inadequate process for identifying, investigating & correcting quality problems.
- Failure to ensure that finished products meet design specifications.
Photo by Joaquin Villaverde Photography
