BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3231423 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00395
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT OF "INVALID IMPEDANCE" WAS CONFIRMED. AS RECEIVED, THE EXTENSION FAILED CONTINUITY TESTING AND ALL CHANNELS MEASURED OPEN. MICROSCOPIC INSPECTION OF THE RETURNED EXTENSION REVEALED SEVERAL BROKEN WIRES BUNDLED IN THE STRAIN RELIEF. AS THE OUTER TUBING OF THE LEAD BODY OF THE EXTENSION WAS NOT BREACHED, THE FRACTURED WIRES ARE CONSISTENT WITH BEING SUBJECT TO STRESS WHILE IMPLANTED. 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

    IT WAS REPORTED THE PT (B)(6) EXPERIENCED A LOSS OF STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN FOR FURTHER INTERROGATION. INTRAOPERATIVE TESTING FOUND THE PROBLEM STEMMED FROM THE PT'S EXTENSION. AS SUCH THE DEVICE WAS REPLACED THEREBY RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322495 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3964780

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other