BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3242969 · Received July 23, 2013

    Report

    Report Number
    3006630150-2013-01554
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. DATA HAD BEEN CORRUPTED IN SEVERAL SEGMENTS OF SEEPROM_1; IMPEDANCE RESULTS, PROGRAMS 6 AND 7. THE CORRUPTED SEEPROM DATA RESULTED IN THE REPORTED BIONIC NAVIGATOR 1.2 ERROR MESSAGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY. MALFUNCTION WAS SUSPECTED AS THE IPG WOULD NOT STORE NEW PROGRAMS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL WOULD SHOW AN ERROR CODE (CRC ERROR). THE PATIENT WILL UNDERGO A BATTERY REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL WOULD SHOW AN ERROR CODE (CRC ERROR). THE PATIENT WILL UNDERGO A BATTERY REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL WOULD SHOW AN ERROR CODE (CRC ERROR). THE PATIENT WILL UNDERGO A BATTERY REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344174 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR