BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2212635 · Received August 11, 2011

    Report

    Report Number
    9614453-2011-06271
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOUND NO SIGNIFICANT ANOMALIES. OUTPUT WAS TESTED AT THE CUT END OF THE EXTENSION. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR ON AN OSCILLOSCOPE THE IPG WAS FUNCTIONALLY OK. ANALYSIS OF THE LEAD FOUND BROKEN CONDUCTORS AT THE PROXIMAL END OF THE LEAD. THE #0 CONDUCTOR WIRE WAS BROKEN AT THE PROXIMAL END UNDER THE #0 CONNECTOR SLEEVE. CONTINUITY WAS ACCEPTABLE ON THE DISTAL SEGMENT OF THE LEAD. THERE WAS A SHORT ACROSS THE #3 AND #4 ELECTRODES, DRY CONDITIONS, DUE TO OVERSTRESS/DAMAGE 25 CM FROM THE DISTAL END. ANALYSIS OF THE EXTENSION FOUND NO SIGNIFICANT ANOMALIES. OUTPUT WAS TESTED AT THE CUT END OF THE EXTENSION AND GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. THE DISTAL SEGMENT OF THE EXTENSION HAD THE #0 CIRCUIT OPEN DUE TO A BROKEN CONDUCTOR WIRE ON THE PROXIMAL SEGMENT OF THE LEAD. ONCE THE SEGMENT WAS DISCONNECTED, CONTINUITY WAS ACCEPTABLE ON ALL CIRCUITS. THERE WERE NO SHORTS THE EXTENSION WAS OK, BUT CUT THROUGH. THIS WAS SUSPECTED EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT LESS STIMULATION AND STIMULATION IN A DIFFERENT AREA FOLLOWING A FALL. IMPEDANCE VALUES INDICATED POSSIBLE LEAD DAMAGE (BREAK). THE NEUROSTIMULATOR, LEAD, AND EXTENSION WERE EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT INCURRED NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THAT, PRIOR TO THE SYSTEM REPLACEMENT, OUT OF RANGE IMPEDANCE VALUES WERE SEEN. A LEAD BREAK WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC EUROPE SARL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU081674V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT # B0313416K| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU081674V| EXPLANTED:| LEAD: MODEL 3487A, LOT # B0313416K| EXPLANTED: