BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2792223 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-10564
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THE COMPLAINT REGARDING NO STIMULATION WAS CONFIRMED: AS RECEIVED, ALL THE WIRES IN THE RETURNED (B)(4) EXTENSION HEADERS ARE BROKEN AND THE WIRES HAVE PULLED BACK INTO THE STRAIN RELIEF. THIS FAILURE IS TYPICAL OF A SEVERE OVERSTRESS CONDITION. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE BROKEN WIRES. 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

    IT WAS REPORTED THE PT (B)(6) WAS NO LONGER FEELING STIMULATION. FLUOROSCOPY WAS USED TO VIEW THE SYSTEM AND IT WAS NOTED THAT THE SCS LEAD EXTENSION APPEARED TO HAVE BEEN STRETCHED. THE LEAD EXTENSION WAS REMOVED AND REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SCS LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 3513024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention