BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLEEXTENSION

    MDR report key: 4142851 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-25621
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT OF "INVALID IMPEDANCE" WAS CONFIRMED. THE EXTENSIONS WERE EXAMINED MICROSCOPICALLY AND BROKEN WIRES WERE OBSERVED IN THE STRAIN RELIEF OF BOTH. CONDUCTIVITY TESTING SHOWED ALL CHANNELS WERE ELECTRICALLY OPEN. AS THERE WERE NO OTHER VISIBLE ANOMALIES OR DAMAGE TO THE EXTENSION AND THE INVALID IMPEDANCE WAS OBSERVED PRIOR TO THE REVISION, THE BROKEN WIRES ARE CONSISTENT WITH AN OVERSTRESS CONDITION THE EXTENSION WAS SUBJECTED TO WHILE IT WAS IN VIVO. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORT#: 1627487-2014-25521 AND 1627487-2014-25522.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591084 SINGLEEXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3383 4400128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other