BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193299 · Received July 13, 2011

    Report

    Report Number
    3007566237-2011-05373
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED PROPHYLACTICALLY FOR BATTERY DEPLETION. NO ADVERSE EVENTS WERE REPORTED.

    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 71 YR CATHETER: MODEL 8709, LOT #J12022R15| IMPLANTED:| EXPLANTED: