BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2429031 · Received January 26, 2012

    Report

    Report Number
    3004209178-2012-00523
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL # 3889-28 LOT # J0231174V IMPLANTED 2002-(B)(6) EXPLANTED N/A; LEAD MODEL # 3889-28 LOT # V151154 IMPLANTED 2008-(B)(6) EXPLANTED N/A; EXTENSION MODEL # 3095-10 LOT # NAH037224V IMPLANTED 2008-(B)(6) EXPLANTED N/A; EXTENSION MODEL # 3095-10 LOT # NAH039710V IMPLANTED 2008-(B)(6) EXPLANTED N/A; PROGRAMMER MODEL # 7435 LOT # NFT069645P.

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL # 3095-10 LOT # NAH037224V EXPLANTED 2012-(B)(6). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 7427 (B)(4) SHOWED BATTERY NORMAL END OF LIFE; TELEMETRY AND OUTPUT OK. FINAL ANALYSIS OF EXTENSION MODEL # 3095-10 LOT # NAH037224H SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A LOW BATTERY WAS REPORTED. THERE WAS AN IMPEDANCE READING >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. ELECTRODE 6 SHOWED >4000OHMS. ADDITIONAL INFORMATION RECEIVED NOTED THAT AS OF 2012-(B)(6) THE DEVICE HAD NOT BEEN REPLACED. THE ISSUE WAS NOT RESOLVED; THEY WERE WAITING FOR FOLLOW UP WITH PHYSICIAN APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE STIMULATOR AND EXTENSION WERE EXPLANTED AND REPLACED 2012-(B)(6). EVENT DESCRIPTION: END OF LIFE, NORMAL BATTERY DEPLETION. PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention