BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE EXTENSION

    MDR report key: 2862107 · Received November 29, 2012

    Report

    Report Number
    1627487-2012-00781
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    THIS LEAD EXTENSION WAS INTENDED FOR PT IMPLANT IN (B)(6). A DIAGNOSTIC TEST PERFORMED FOLLOWING PLACEMENT OF THE DEVICE FOUND INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL CONTACTS. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE UNDERTAKEN TO RESOLVE THIS MATTER; HOWEVER, THE PROBLEM PERSISTED. A NEW LEAD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 3467879

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention