BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 5998833 · Received October 4, 2016

    Report

    Report Number
    3006630150-2016-02804
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2208-50 SERIAL #: 173499/174850 DESCRIPTION: ST LINEAR LEAD 50CM MODEL#: SC-2208-70 SERIAL #: 147351/178028 DESCRIPTION: ST LINEAR LEAD 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED WITH MRI COMPATIBLE DEVICES. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THESE WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG DOES NOT HOLD A CHARGE AND WILL NOT CHARGE COMPLETELY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN IPG AND LEADS WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG DOES NOT HOLD A CHARGE AND WILL NOT CHARGE COMPLETELY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN IPG AND LEADS WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647732 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR