BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2822819 · Received November 7, 2012

    Report

    Report Number
    3006630150-2012-02042
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL TESTS PERFORMED. THE IPG WAS EXPLANTED DUE TO SURGICAL PAIN UNRELATED TO THE DEVICE. EXCESSIVE BATTERY DEPLETION WAS NOTED AFTER THE EXPLANT PROCEDURE. THE DEVICE EXHIBITED ANALOG INTEGRATED CIRCUIT (AIC) DAMAGE. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC. (B)(4). IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE. THE PADDLE LEAD WAS CUT. THIS KIND OF DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-50, SERIAL: (B)(4), LEAD, 50CM DESCRIPTION: 434976.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE LEAD AND POCKET SITES. THE PHYSICIAN BELIEVES THE PATIENT'S SYMPTOMS WERE PROCEDURE RELATED AND CAUSED HER FIBROMYALGIA TO FLARE UP. THE PATIENT WAS EXPLANTED AND IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE LEAD AND POCKET SITES. THE PHYSICIAN BELIEVES THE PATIENT'S SYMPTOMS WERE PROCEDURE RELATED AND CAUSED HER FIBROMYALGIA TO FLARE UP. THE PATIENT WAS EXPLANTED AND IS 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 69 YR Required Intervention