BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1062120 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-03321
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 20, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT SHOCKING WHEN IN A RECLINING POSITION. FOLLOWING THE SHOCKING THE PT LOST STIMULATION ON THE RIGHT SIDE. THE PT WAS STILL RECEIVING THERAPY ON THE LEFT SIDE. TELEMETRY REVEALED IMPEDANCES GREATER THAN 4000 OHMS ON ALL BIPOLAR PAIR WITH THE EXCEPTION OF 5+, 6- WHICH WAS 2624 OHMS, INDICATING OPEN CIRCUIT. NO STIMULATION COULD BE PROVIDED. THE PT'S NEUROSTIMULATOR WAS TURNED OFF AT THE PT'S REQUEST DUE TO CONCERN OF SHOCKING. THE PT WAS SENT FOR X-RAYS AND TOLD TO FOLLOW-UP WITH THE NEUROSURGEON FOR LEAD REVISION. THE PT OUTCOME WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 EXTENSION MODEL 7489 LOT# NHU069752V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU069675V| IMPLANTED:| PROGRAMMER MODEL 7435| EXPLANTED:| IMPLANTED:| LEAD MODEL 3998 LOT #J0412296V