BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 2913963 · Received January 14, 2013

    Report

    Report Number
    3006630150-2013-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. THE PHYSICIAN DID NOT SUSPECT MALFUNCTION WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3304-25 SERIAL #: (B)(4), DESCRIPTION: SPLITTER 2X4-25 CM, MODEL #: SC-3138-35, SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM, MODEL #: SC-9004-35, SERIAL #: (B)(4), DESCRIPTION: PRECISION CONNECTOR M1 35CM MODEL #: SC-8216-70, SERIAL #: 297234, DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO FAILED HARDWARE. NO OTHER KNOWN INFORMATION YET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO FAILED HARDWARE. NO OTHER KNOWN INFORMATION YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21602 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 197153

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention