BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2101006 · Received May 24, 2011

    Report

    Report Number
    3006630150-2011-00729
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF MEASURED 94 MVDC PER DAY, THIS EXCEEDS THE TYPICAL BATTERY DEPLETION RATE. THE AIC-U1 DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC-U1. THE BATTERY PROFILE REVEALED THAT THE AIC-U1 WAS DAMAGED PRIOR THE EXPLANT PROCEDURE. THE PATIENT HAD A LEAD REVISION PRIOR THE EXPLANT PROCEDURE BUT IT COULD NOT BE DETERMINED IF ELECTROCAUTERY WAS USED. THE BATTERY AND ITS INSULATION WERE DAMAGED BECAUSE THE FACILITY STERILIZED THE DEVICE AFTER IT WAS EXPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT HE PATIENT WAS HAVING TO CHARGE HER IPG MORE OFTEN. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE IPG WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT HE PATIENT WAS HAVING TO CHARGE HER IPG MORE OFTEN. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE IPG WAS REPLACED AND 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-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention