BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1162242 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05783
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    July 1, 2008
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT STIMULATION WAS NOT AS EFFECTIVE AFTER THE STIMULATOR WAS REPLACED. PRIOR TO REPLACEMENT AND INTRAOPERATIVELY DURING THE REPLACEMENT THE IMPEDANCE READINGS WERE FINE. AT THE TIME OF THE REPORT, THERE WAS IMPEDANCE READINGS >4000 OHMS ON SOME BIPOLAR PAIRS. AN OPEN CIRCUIT WAS SHOWING ON 0-3 CONTACTS, PAIR 2-3 WAS THE ONLY PAIR WITH NORMAL IMPEDANCES AT 843 OHMS. ALL OTHER PAIRS WERE RUNNING HIGH AT 2000-3030 OHMS. REPROGRAMMING WAS ATTEMPTED, BUT THE PATIENT ONLY GOT A LIGHT SENSATION OF STIMULATION, EVEN WITH THE 2-3 COMBINATION. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, 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 50 YR Required Intervention LEAD: MODEL 3487A| EXPLANTED: