BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3771911 · Received April 25, 2014

    Report

    Report Number
    3006630150-2014-00880
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO CONTACTS WERE LEFT INSIDE THE PATIENT. SC-2316-50E (SN/(B)(4)) AS NO ANOMALIES OR DEVIATIONS WERE FOUND DURING THE COMPLAINT INVESTIGATION SITE (CIS) REVIEW, THERE IS NO REASON TO SUSPECT A MANUFACTURING DEFECT AS THE SOURCE OF THE REPORTED COMPLAINT. SC-2316-50E (B)(4): DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF THE LEAD BODY BEING CUT IN HALF HAD BEEN CONFIRMED. ONLY THE DISTAL PORTION OF THE LEAD WAS RETURNED, THE PROXIMAL PORTION WAS NOT RETURNED. DAMAGE OCCURRED DURING THE EXPLANT PROCEDURE; THEREFORE, IT IS NOT CONSIDERED A FAILURE. ADDITIONALLY, VISUAL INSPECTION REVEALED THAT THE DISTAL END WAS FRACTURED BETWEEN TWO ELECTRODES. (B)(4). THE ROOT CAUSE OF THE DISTAL END DAMAGE WAS UNKNOWN.

    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 AND SPLITTER 2X8 KITS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THE PHYSICIAN WAS HAVING DIFFICULTY REMOVING THE LEADS AND THE LEADS WERE CUT INTO HALF. THE LEAD WAS ALREADY CUT UPON REMOVAL. THE OTHER HALF OF THE LEADS WAS RETRIEVED WHILE THE OTHER HALF REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WENT TO THE EMERGENCY ROOM TO HAVE THE OTHER HALF PULLED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THE PHYSICIAN WAS HAVING DIFFICULTY REMOVING THE LEADS AND THE LEADS WERE CUT INTO HALF. THE LEAD WAS ALREADY CUT UPON REMOVAL. THE OTHER HALF OF THE LEADS WAS RETRIEVED WHILE THE OTHER HALF REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WENT TO THE EMERGENCY ROOM TO HAVE THE OTHER HALF PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251539 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention