BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3072592 · Received April 18, 2013

    Report

    Report Number
    1627487-2013-05562
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT #: 1627487-2013-05563. IT WAS REPORTED THE PATIENT IS UNABLE TO RECEIVE ADEQUATE COVERAGE. REPROGRAMMING WAS UNSUCCESSFUL. THE PATIENT MAY UNDERGO X-RAYS FOR FURTHER INVESTIGATION. IT WAS ALSO REPORTED THE PATIENT'S RECEIVER MIGHT BE EXPLANTED AND REPLACED (WITH AN IPG) ON A FUTURE DATE. THE REASON IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168388 UNKNOWN SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention