BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2161112 · Received June 17, 2011

    Report

    Report Number
    3007566237-2011-04547
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    July 27, 2010
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED S2 BATTERY RESISTANCE HIGH. THE BATTERY WAS AT 2.99 VOLTS AFER 63 DAYS, WELL ABOVE THE EXPECTED END-OF-SERVICE VOLTAGE OF 2.815 VOLTS. THE BATTERY HAD HIGHER THAN EXPECTED RESISTANCE VALUES (WITH THE HIGHEST RESISTANCE OF 317.2 OHM), WHICH EXCEEDED THE BATTERY SPECIFICATION REQUIREMENT OF <= 317 OHM DURING 30 UA DISCHARGE TO 2.815 VOLTS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER. THE RETURN PAPERWORK INDICATED THAT THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION; ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 6 MONTHS. THERE WAS REPORTED TO BE NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP UNDERWENT ROUTINE ANALYSIS. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (2000 MCG/ML. 840.6 MCG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR