BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3133356 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01087
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE PAIN IN THE PATIENT¿S POCKET SITE WAS INVESTIGATED. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD PASSED THE PHOTOGRAPHIC IMAGING TEST PERFORMED. THE PADDLE LEAD WAS CUT. DAMAGE TO THE LEAD WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE IPG SITE RELATED TO SITTING ON A BONY PROMINENCE AND CAUSING DISCOMFORT AT THE PATIENT¿S PELVIC AREA. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE IPG SITE RELATED TO SITTING ON A BONY PROMINENCE AND CAUSING DISCOMFORT AT THE PATIENT¿S PELVIC AREA. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235098 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention