BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3936198 · Received July 15, 2014

    Report

    Report Number
    3006630150-2014-01598
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2352-50, SERIAL/LOT # (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE MODEL # SC-2352-50, SERIAL # (B)(4), LEAD PASSED VISUAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE LEAD IS INTACT AND NO PARTS OF IT ARE MISSING. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LEAD, S/N (B)(4), REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG, AND WAS EXPERIENCING PAIN AT THE IPG SITE. IN ADDITION, THE PATIENT HAD LOST STIMULATION ON THE RIGHT SIDE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE POCKET WAS REPOSITIONED. DURING THE PROCEDURE, ONE OF THE LEADS WAS REPLACED AS THE LEAD WAS FRACTURED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG, AND WAS EXPERIENCING PAIN AT THE IPG SITE. IN ADDITION, THE PATIENT HAD LOST STIMULATION ON THE RIGHT SIDE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE POCKET WAS REPOSITIONED. DURING THE PROCEDURE, ONE OF THE LEADS WAS REPLACED AS THE LEAD WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411845 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention