BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1941141 · Received December 22, 2010

    Report

    Report Number
    3007566237-2010-10701
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    January 5, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL PUMP ANALYSIS REVEALED THAT S2 BATTERY RESISTANCE WAS HIGH - THE BATTERY HAD HIGHER THAN EXPECTED RESISTANCE VALUES, WHICH EXCEEDED THE BATTERY SPECIFICATION REQUIREMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH NO ADDITIONAL INFORMATION.

    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 53 YR CATHETER: MODEL 8598, LOT # N001261202| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| CATHETER: MODEL 8596, LOT # B011582N14| IMPLANTED: