BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3201990 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01356
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL, AND PERFORMANCE TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE HAD CAUSED THE POCKET SITE PAIN WAS INVESTIGATED. CURRENT LEAKAGE TESTS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. RESIDUAL GAS ANALYSIS VERIFIED THAT THE DEVICE INSULATION HAD NOT BEEN COMPROMISED. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD HAD BEEN DAMAGED. THE BODY WAS CUT, AND THREE ELECTRODE CONTACTS WERE MISSING FROM THE PADDLE. THE CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE. THE ROOT CAUSE OF THE THREE MISSING ELECTRODES WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN. THE PHYSICIAN BELIEVED THAT THE IPG WAS RESTING ON THE SCIATIC NERVE CAUSING THE PATIENT'S PAIN, HOWEVER, AN X-RAY WAS TAKEN AND CONFIRMED THAT THE IPG WAS NOT RESTING ON THE SCIATIC NERVE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET PAIN. THE PHYSICIAN BELIEVED THAT THE IPG WAS RESTING ON THE SCIATIC NERVE CAUSING THE PATIENT'S PAIN, HOWEVER, AN X-RAY WAS TAKEN AND CONFIRMED THAT THE IPG WAS NOT RESTING ON THE SCIATIC NERVE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301266 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention