BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2241427 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01403
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, AND ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. 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, CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE PATIENT'S LEAD REVISION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING. BSN REPRESENTATIVE ANALYZED THE PATIENTS DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING. BSN REPRESENTATIVE ANALYZED THE PATIENTS DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND IS REPORTEDLY DOING WELL.

    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 57 YR Required Intervention