BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3231515 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-10233
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-10226. THE PATIENT (B)(6) REPORTED ALL SEVEN STIMULATION PROGRAMS WERE SUDDENLY DELETED. A CT SCAN WAS PERFORMED WITH NO ANOMALIES NOTED. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCES ON ALL ODD-NUMBERED CONTACTS AND THE IPG SOFTWARE WOULDN'T ALLOW NEW PROGRAMS TO BE DOWNLOADED. THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION. THE IPG WAS REPLACED WHICH RESOLVED THE REPORTED ISSUE. PLEASE NOTE: IT IS POSSIBLE THE LEAD EXTENSIONS WERE ALSO EXPLANTED AND REPLACED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT; THEREFORE, THE LEAD EXTENSIONS WILL BE REPORTED AS DEVICE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322247 UNK SCS LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SCS LEAD (X2), MODEL: UNK| IMPLANT DATE