BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1963380 · Received December 20, 2010

    Report

    Report Number
    3006630150-2010-02116
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS RETURNED FOR ANALYSIS AND PREMATURE BATTERY DEPLETION WAS VERIFIED. THE IPG PASSED VISUAL AND PERFORMANCES TESTS DONE. THE ANALOG IC WAS DAMAGED DUE TO MONOPOLAR ELECTROCAUTERY USED DURING A PREVIOUS NON DEVICE RELATED PROCEDURE WHICH RESULTED IN THE BATTERY DEPLETION. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENTS WHICH DAMAGES THE ANALOG IC. CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (REFER TO PHYSICIAN'S IMPLANT MANUAL (B)(4)).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON DEVICE RELATED PROCEDURE, THE PATIENT'S IPG HAS BEEN DEPLETING QUICKLY. A BSN REP ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A NON DEVICE RELATED PROCEDURE THE PATIENT'S IPG HAS BEEN DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT SURGERY HAS BEEN RECOMMENDED.

    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 50 YR Required Intervention