BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173456 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01067
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. ADDITIONAL TESTING REVEALED THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. 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. THE COMPLAINT REGARDING COMMUNICATION ISSUES BETWEEN THE IPG AND THE REMOTE CONTROL WAS NOT CONFIRMED. THE IPG PASSED TELEMETRY PROTOCOL TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IPG FOLLOWING A PREVIOUS LEAD REVISION. 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 THE PATIENT WAS EXPERIENCING COMMUNICATION ISSUES BETWEEN THE REMOTE CONTROL AND THE IPG FOLLOWING A PREVIOUS LEAD REVISION. 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 46 YR Required Intervention