BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1022836 · Received March 28, 2008

    Report

    Report Number
    2029203-2008-00171
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR IPG AND LEAD WAS COMPLETED AND NO ANOMALIES WERE NOTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A LOSS OF THERAPY AND DECIDED TO EXPLANT HER SYSTEM. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN DISCOVERED THAT CONTACTS WERE DETACHED FROM THE LEAD. ALL CONTACTS WERE REMOVED FROM THE PT. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SC-8116-70