BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3092900 · Received May 3, 2013

    Report

    Report Number
    3006630150-2013-00909
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: 30 CM SPLITTER KIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2316-50E, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD SC-2316-50E / (B)(4). THE COMPLAINT OF HIGH IMPEDANCE HAD BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THE LEAD PROXIMAL END WAS FRACTURED BETWEEN TWO CONTACTS. THE DAMAGED PROXIMAL END RESULTED IN FRACTURED CABLES ALONG THE PROXIMAL ARRAY. MODEL # SC-3400-30: (B)(4). DEVICE EVALUATION INDICATED THAT THE SPLITTERS PASSED VISUAL, ELECTRICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE SPLITTERS WERE VERIFIED TO BE NORMAL. MODEL # SC-2316-50E / (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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE LEAD INTO THE SPLITTER. THE NORMALLY 35 MINUTE TRIAL, ACCORDING TO THE PHYSICIAN, TOOK 2 HOURS TO COMPLETE. THE TRIAL WAS EVENTUALLY ABORTED AND NOTHING WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE LEAD INTO THE SPLITTER. THE NORMALLY 35 MINUTE TRIAL, ACCORDING TO THE PHYSICIAN, TOOK 2 HOURS TO COMPLETE. THE TRIAL WAS EVENTUALLY ABORTED AND NOTHING WAS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194737 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other