BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1162264 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05800
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 19, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING STIMULATION IN THE WRONG LOCATION AND A SHOCKING/JOLTING SENSATION. THE SYMPTOMS BEGAN WITHIN A FEW MONTHS OF HAVING THEIR LAST NEUROSTIMULATOR REPLACED. THE PATIENT UNDERWENT REPLACEMENT OF THEIR OLD DEVICE IN 2007. WITHIN A FEW MONTHS THE NEW DEVICE "STARTED ACTING STRANGE". THE PATIENT RECEIVED A COUPLE OF STRONG SHOCKS AND THE UNIT WAS BARELY WORKING IN THE LOWER LUMBAR AREA. THE PATIENT'S LEGS AND FEET WERE THE ONLY AREAS THAT WERE RECEIVING THE FULL ELECTRONIC IMPULSES. THE DEVICE BEGAN TO GET PAINFUL TO USE DUE TO THE IMPULSES BEING SO STRONG IN THE LEGS. EVENTUALLY, THE IMPULSES WERE NO LONGER IN THE LOWER LUMBAR AREA. "THE BATTERY WAS GONE (AFTER NINE MONTHS) AND IT ONLY WORKED PROPERLY FOR A FEW MONTHS." IT WAS ALSO REPORTED "THE EQUIPMENT USED TO TAKE READINGS ON THE STIMULATORS DID NOT GIVE ACCURATE READOUTS ON PROBLEMS WITH THE NEUROSTIMULATORS." THE PATIENT IS REPORTEDLY WAITING FOR REPLACEMENT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention EXPLANTED :| EXTENSION: MODEL 7489| EXPLANTED:| LEAD: MODEL 3891| EXTENSION: MODEL 7489| EXPLANTED :