BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3781373 · Received April 30, 2014

    Report

    Report Number
    3006630150-2014-00993
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TESTS PERFORMED. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD, APPROXIMATELY 23.31 CM FROM THE DISTAL END. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLICK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE LEAD BODY. SC-2218-50 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 Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50, SERIAL/LOT # (B)(4), DESCRIPTION:LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS DISPLAYING VERY HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE PHYSICIAN EXPLANTED THE LEAD DUE TO LEAD FRACTURE. THE FRACTURE WAS LOCATED NEAR THE CLICK ANCHOR SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD WAS DISPLAYING VERY HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE PHYSICIAN EXPLANTED THE LEAD DUE TO LEAD FRACTURE. THE FRACTURE WAS LOCATED NEAR THE CLIK ANCHOR SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259383 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention