BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943775 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02114
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION INDICATED THAT THE IPG PASSED PHOTOGRAPHIC TESTS PERFORMED. TESTING REVEALED THAT THE DAMAGE DONE TO THE ANALOG IC RESULTED IN THE FAST BATTERY DEPLETION OF THE IPG. THE BATTERY PROFILES REVEALED EXCESSIVE BATTERY DEPLETION POST LEAD REVISION. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABEL WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL (B)(4) . AB)

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION PROCEDURE, THE PT REPORTED DIFFICULTY CHARGING HER IPG. THE PHYSICIAN DECIDED THAT THE IPG SHOULD BE REPLACED, SINCE IT APPEARED TO EXHIBIT RAPID BATTERY DEPLETION. THE IPG WAS REPLACED AND THE PT WAS ABLE TO RECEIVE PROPER STIMULATION COVERAGE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION PROCEDURE THE PATIENT REPORTED DIFFICULTY CHARGING HER IPG. THE PHYSICIAN DECIDED THAT THE IPG SHOULD BE REPLACED, SINCE IT APPEARED TO EXHIBIT RAPID BATTERY DEPLETION. THE IPG WAS REPLACED AND THE PATIENT WAS ABLE TO RECEIVE PROPER STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention