BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1080750 · Received July 23, 2008

    Report

    Report Number
    6000032-2008-04300
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO. MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED INTERMITTENT STIMULATION. THE HEALTH CARE PROFESSIONAL REPORTED THE BATTERY WAS DEAD. THE PT RECEIVED NO STIMULATION. THE NEUROSTIMULATOR AND EXTENSION WERE REPLACED. THE PT RECEIVED PAIN RELIEF AFTER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. MED REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3487A LOT# J0118361V| EXPLANTED:| EXTENSION MODEL 7495-25 LOT# NAF000930V