BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2760035 · Received September 26, 2012

    Report

    Report Number
    3006630150-2012-01806
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110, SERIAL # (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF HIGH IMPEDANCES WAS CONFIRMED. THE LEAD ANALYSIS INDICATED THAT ONE CABLE EXHIBITED TARNISH THAT SUGGESTS AT LEAST SOME CABLES WERE FRACTURED WHILE STILL INSIDE THE PATIENT. FULL TESTING COULD NOT BE PERFORMED DUE TO ALL SUBSEQUENT LEAD CABLES BEING CUT/TORN DURING THE EXPLANT PROCEDURE. THE LEAD BODIES WERE NOT RETURNED. THE IPG PASSED ALL VISUAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. THROUGH TROUBLESHOOTING AND THE IPG DATABASE ANALYSIS, HIGH IMPEDANCES WERE NOTED ON ELEVEN CONTACTS OF THE PADDLE LEAD. THE PATIENT UNDERWENT A REVISION, DURING WHICH, THE PHYSICIAN EXPLANTED THE PADDLE LEAD AND THE IPG. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. THROUGH TROUBLESHOOTING AND THE IPG DATABASE ANALYSIS, HIGH IMPEDANCES WERE NOTED ON ELEVEN CONTACTS OF THE PADDLE LEAD. THE PATIENT UNDERWENT A REVISION, DURING WHICH, THE PHYSICIAN EXPLANTED THE PADDLE LEAD AND THE IPG. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR