BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2172356 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04752
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRIMARY FINDING WAS BATTERY RESISTANCE HIGH. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1247 OHMS. LOGS SHOWED MULTIPLE LOW BATTERY RESETS WATCH DOG NOT PROPERLY SERVICED, A LEGITIMATE ERI, AND PUMP IN SAFE STATE. THE BATTERY LOGS OF THE BCT FILE SHOWED A VOLTAGE DROP OF .65V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS EXPLANTED ON (B)(6) 2011 FOR "END OF LIFE >1 MONTH". THIS WAS REPORTED AS A PROPHYLACTIC REMOVAL TO AVOID IN-VIVO BATTERY DEPLETION. NO INJURY OR PT PROBLEM WAS REPORTED. THE DEVICE WAS RETURNED TO MEDTRONIC FOR "DISPOSAL ONLY". ADDITIONAL INFO WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CATHETER: MODEL 8709, LOT# J52949R31| EXPLANTED:| IMPLANTED: