BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4090676 · Received September 15, 2014

    Report

    Report Number
    3006630150-2014-02093
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02(SN:(B)(4) ) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, 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 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. SC-2352-50(SN:(B)(4)) VISUAL INSPECTION REVEALED THE LEAD BODIES HAD PRONOUNCED KINKS WHERE THE LEAD APPEARED TO HAVE BEEN SUTURED. CABLES WERE SEVERED AT THIS SPOT. THERE WERE NO EXPOSED CABLES. IT APPEARED TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. A REVIEW OF THE STERILIZATION RECORDS DID NOT FIND ANY ANOMALIES OR DEVIATIONS. THE SOURCE OF THE POCKET PAIN COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S LEADS WERE SENT IN BECAUSE OF HIGH IMPEDANCES DETECTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A LOT OF PAIN AT THE STIMULATOR SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A LOT OF PAIN AT THE STIMULATOR SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A LOT OF PAIN AT THE STIMULATOR SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570133 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention