BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4695710 · Received April 15, 2015

    Report

    Report Number
    3006630150-2015-00896
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 24, 2015
    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

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8120-70 SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    SC-1110 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-8120-70 (SN (B)(4)) THE DAMAGE TO THE LEAD WAS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND IT WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A SCAR TISSUE HAD BUILT UP AROUND THE IPG SITE AND WAS CAUSING THE PATIENT PAIN IN THE HIP AND LEG. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A SCAR TISSUE HAD BUILT UP AROUND THE IPG SITE AND WAS CAUSING THE PATIENT PAIN IN THE HIP AND LEG. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251347 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention