BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6175474 · Received December 15, 2016

    Report

    Report Number
    3006630150-2016-03626
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-2317-50 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT HAS BEEN CONFIRMED. X-RAY INSPECTION FOUND THAT ONE CABLE WAS FRACTURED AT APPROXIMATELY 4 CM FROM THE PROXIMAL TIP AND THE CABLE WAS EXPOSED. IT APPEARS THAT THE FRACTURED CABLE WAS SHEARED BY A SURGICAL TOOL. THE FRACTURED CABLE RESULTED IN LOSS OF STIMULATION. THE REPORTED COMPLAINT STATES THAT PATIENT HAD A FALL AT WORK AND HAS NOT BEEN ABLE TO GET THE SAME COVERAGE/PAIN RELIEF SINCE. ADDITIONALLY, VISUAL INSPECTION REVEALED THAT LEAD TAILS WERE CLEANLY CUT THE CABLES ARE NOT EXPOSED. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. SC-2317-50 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. SC-4316 (LN: 18504581) DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR HAS A TORN EYELET WITH MISSING SILICONE MATERIAL. SC-4318 (LN: 18338769) DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. SC-2317-50 (SN: (B)(4)) A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLIK ANCHOR WAS NOT LEFT IN THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2317-50 SERIAL/LOT#: (B)(4) DESCRIPTION: INFINIONTM CX 50 CM LEAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD ONE CONTACT OUT ON THE LEAD THAT HAD NOT MIGRATED. IT WAS NOTED THAT THE CONTACT WAS FALLING OFF WHEN THE PHYSICIAN TOOK OUT THE LEADS FROM THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN BOTH LEADS WERE REPLACED. IT WAS REPORTED THAT THERE WAS NO CONTACT LEFT IN THE PATIENT'S BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION. X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION. X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION. X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828717 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention