BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3242745 · Received July 23, 2013

    Report

    Report Number
    3006630150-2013-01546
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    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

    DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR PASSED VISUAL TESTS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. THE CLIK ANCHOR IS INTACT AND NO PARTS OF IT ARE MISSING. THE CLIK ANCHOR WAS TESTED WITH A KNOWN GOOD LEAD AND IT WAS LOCKED DOWN WITHOUT ANY ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, THE CLIK ANCHOR WAS REPLACED DUE TO A SUSPECTED MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, THE CLIK ANCHOR WAS REPLACED DUE TO A SUSPECTED MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344171 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 15909281

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR