BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1083089 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04304
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION A COUPLE OF DAYS AFTER A BONE DENSITY TEST. THE STIMULATION GOES UP THE MIDDLE OF THE BACK RATHER THAN DOWN THE LEGS. THE PATIENT WAS REPORTED IN FAIR CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178200804305.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD MODEL 3891 LOT# V002081| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU037145V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEUROSTIMULATOR MODEL 7427| LOT# NFE150853H| IMPLANTED:| LEAD MODEL 3487A LOT# J0427678V| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU057478V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3891 LOT# J0437524V| EXPLANTED:| EXPLANTED:| LEAD MODEL 3887 LOT# V001392| EXPLANTED:| EXTENSION MODEL 7489 LOT# NHU097205V| EXTENSION MODEL 7489 LOT# NHU089179V| EXTENSION MODEL 7489 LOT# NHU057477V