BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2093939 · Received May 16, 2011

    Report

    Report Number
    9614453-2011-03545
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    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

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF NEUROSTIMULATOR LOT NFE707859S REVEALED NO SIGNIFICANT ANOMALIES. THE DEVICE WAS FUNCTIONALLY OKAY. THE COMPLAINT RELATED TO HIGH IMPEDANCE AND NO TELEMETRY COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL ANALYSIS TESTING. THERE WAS A PUNCHOUT HOLE IN THE #3 SETSCREW GROMMET. IT IS UNK IF THIS OCCURRED AT EXPLANT OR SOMETIME PRIOR. THE PUNCHOUT HOLE IS UNRELATED TO THE COMPLAINT OF NO TELEMETRY AND HIGH IMPEDANCES. THERE WAS GOOD STABLE OUTPUT ON EACH ELECTRODE PAIR AT THE SETTINGS THAT THE INS HAD WHEN RECEIVED FOR ANALYSIS. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR REFERENCED TO THE #0 ELECTRODE ON BOTH CHANNELS. THE OUTPUT MATCHED THE PROGRAMMED SETTINGS. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. THE INS BATTERY STATUS SHOWN ON THE 8840 PROGRAMMER DURING TESTING WAS OK, 3.06 VOLTS, AND <20% CAPACITY USED. THE DEVICE WAS INTERROGATED MULTIPLE TIMES WHILE RUNNING AT BODY TEMPERATURE AND NO TELEMETRY ISSUES WERE OBSERVED. DUE TO THE COMPLAINT OF HIGH IMPEDANCE, A NON-STANDARD TEST WAS DONE TO CHECK THAT THE DEVICE WAS MEASURING IMPEDANCES CORRECTLY. TWO KNOWN GOOD EXTENSIONS AND TWO KNOWN GOOD LEADS WERE CONNECTED TO THE DEVICE. THE ELECTRODES OF THE LEADS WERE PLACED IN 0.9% SALINE SOLUTION. IMPEDANCES WERE TAKEN USING AN 8840 PROGRAMMER. NORMAL IMPEDANCES WERE OBSERVED ON EVERY ELECTRODE PAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED BECAUSE OF HIGH IMPEDANCES. DURING INTERROGATION TELEMETRY WAS ABORTED. THERE WAS NO MORE INTERROGATION POSSIBLE. THE DEVICE WAS EXPLANTED. THE DEVICE WAS REPLACED AND THE NEW DEVICE WORKED "BRILLIANTLY". THE PT HAD NO INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention