BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3241467 · Received July 22, 2013

    Report

    Report Number
    3006630150-2013-01545
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL AND ELECTRICAL TESTS PERFORMED. THE COMPLAINT OF NO TELEMETRY WAS CONFIRMED. X-RAY INSPECTION SHOWED THAT ONE OF THE ANTENNA COIL WIRES WAS OPEN. AN OPEN CONNECTION TO THE TELEMETRY COIL PREVENTED PROPER TELEMETRY FUNCTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY COMMUNICATING HER REMOTE CONTROL TO HER IPG. AN IMAGE OF THE POCKET SITE CONFIRMED THAT THE IPG WAS NOT FLAT TO THE SKIN. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO SUSPECTED MALFUNCTION. THE PATIENT DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY COMMUNICATING HER REMOTE CONTROL TO HER IPG. AN IMAGE OF THE POCKET SITE CONFIRMED THAT THE IPG WAS NOT FLAT TO THE SKIN. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO SUSPECTED MALFUNCTION. THE PATIENT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340064 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1