BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2904795 · Received January 9, 2013

    Report

    Report Number
    3007566237-2013-00090
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8703W, LOT# L40842, IMPLANTED: (B)(6) 1997. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO SIGNIFICANT ANOMALIES. THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING. THERE WAS NO COMPLAINT AGAINST THE PUMP. IT WAS RETURNED FOR DISPOSAL ONLY. THERE WAS A MOTOR STALL RECOVERY IN THE LOGS. A MOTOR STALL RECOVERY WAS AN INDICATION THAT IN THE PUMP'S LIFE THERE WAS AT ONE TIME A MOTOR STALL AND THEN RECOVERY. AFTER DOING DESTRUCTIVE ANALYSIS IT WAS FOUND NOTHING SIGNIFICANT THAT MAY CAUSE THE MOTOR STALL. THIS PUMP ALSO HAD A NORMAL ERI OCCURRED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL REPORTED INFORMATION INDICATED THAT THE PATIENT'S NURSING HOME STAFF DID NOT SCHEDULE A REFILL. THE PATIENT EXPERIENCED REBOUND SPASTICITY AND A FEVER. A DOSE REDUCTION WAS DONE. THE PATIENT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY/ILLNESS. IT WAS ALSO REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED FOR END OF LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL. THE HEALTHCARE PROVIDER (HCP) NOTICED THE PATIENT HAD MISSED THEIR APPOINTMENT AND WAS "GUESS" THAT THE PUMP WAS "COMPLETELY" EMPTY. IT WAS NOTED THAT THE HCP WAS NOT AWARE OF ANY SYMPTOMS AND THEN NOTED THAT THE PATIENT WAS "SICK", THERE WERE NO SYMPTOMS NOTED. IT WAS UNCLEAR IF THE PATIENT BEING "SICK" WAS RELATED TO THE DEVICE. THE SYSTEM WAS USED TO INFUSE LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11799 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR