BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2181465 · Received July 5, 2011

    Report

    Report Number
    3007566237-2011-05062
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL ANALYSIS OF THE PUMP REPORTED HIGH S2 BATTERY RESISTANCE. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1585 OHMS. THE PUMP HAD A VOLTAGE DROP AFTER BENCH TESTING (BCT) OF 0.82 V. IN ADDITION, RESIDUE WAS NOTED IN AND AROUND BOTTOM JEWEL FOR ROTOR MAGNET, ON THE BOTTOM SIDE OF THE INNER COVER AND ON TOP AND BOTTOM SURFACES OF GEAR WHEEL 3.

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED DUE TO BATTERY DEPLETION. NO ADVERSE EVENTS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELAE.

    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 59 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J55519R34| EXPLANTED: