BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3903366 · Received June 30, 2014

    Report

    Report Number
    3006630150-2014-01484
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM; MODEL #: SC-4316, LOT #: 16240016, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE; SC-2316-50 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE LEADS PASSED MECHANICAL TEST PERFORMED. IT REVEALED THAT BOTH LEAD BODIES HAD PRONOUNCED KINKS APPROXIMATELY 8 INCHES FROM THE PROXIMAL ENDS, WHERE THE LEADS APPEARED TO HAVE BEEN SUTURED. CABLES WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITES WERE 1 CM FROM THE CLIK ANCHOR SETSCREW MARKS. THIS APPEARED TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. THE COMPLETELY SEVERED CABLES WERE THE REASON FOR THE HIGH IMPEDANCES OBSERVED. THE FRACTURED CABLES WERE STILL CONTAINED INSIDE THE LEAD BODY/LUMEN. SC-4316 (LOT# 16240016) DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR PASSED VISUAL TEST PERFORMED. ONE OF THE ASSOCIATED ANCHORS HAD EYELET DAMAGE WITH SOME MISSING SILICONE. (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE MISSING SILICONE FROM THE CLIK ANCHOR WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON ALL ELECTRODES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS WERE REPLACED AND CLIK ANCHORS WERE EXPLANTED. DEVICE MALFUNCTION WAS SUSPECTED WITH THE LEADS. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON ALL ELECTRODES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN TWO LEADS WERE REPLACED AND CLIK ANCHORS WERE EXPLANTED. DEVICE MALFUNCTION WAS SUSPECTED WITH THE LEADS. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379843 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention