BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2100326 · Received May 13, 2011

    Report

    Report Number
    3007566237-2011-03492
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH FAULTY BATTERIES 2 TIMES. SEE ALSO MFR REPORT # 3007566237201103490. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LOT # UNKNOWN| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| IMPLANTED: