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Fleming, Nolen & Jez Investigating SynchroMed II for Serious Injuries

June 2, 2017 · FLEMING | NOLEN | JEZ, L.L.P.

The attorneys at Fleming, Nolen & Jez are currently investigating serious injuries and fatalities resulting from accidental overdoses/underdoses, side effects and safety defects resulting from the use of SynchroMed II.

The battery is expected to last up to 4 years.

The SynchroMed pumps used in spasticity are often called Baclofen pumps.

The pump can be programmed to deliver continuous, intermittent or complex circadian administrations.

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.

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.

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 underdose which can lead to serious adverse health consequences.

Complications 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.

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.

Old entries as far back as 1998 were published in this year’s MAUDE reporting. Those older reports were removed from the current tallies above.

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