BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4791879 · Received May 22, 2015

    Report

    Report Number
    3006630150-2015-01309
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 5, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN ONLY THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE FOR IMPROVED PROGRAMMING AVAILABILITY. IT WAS ALSO REPORTED THAT NONFUNCTIONING CONTACT ON THE LEAD MEANT HIGH IMPEDANCE VALUE. THE PATIENT WAS REPORTEDLY DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT HOLDING A CHARGE AND TWO CONTACTS ON THE LEAD WERE NOT FUNCTIONING. THE PATIENT WILL UNDERGO A SPINAL CORD STIMULATOR REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS NOT HOLDING A CHARGE AND TWO CONTACTS ON THE LEAD WERE NOT FUNCTIONING. THE PATIENT WILL UNDERGO A SPINAL CORD STIMULATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335899 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR