BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3123493 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-00261
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 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

    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 SUDDEN LOSS OF STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN FOR FURTHER INTERROGATION. INTRAOPERATIVE TESTING ISOLATED THE ISSUE TO THE EXTENSION AS THE DEVICE WAS FOUND TO BE FRACTURED. THE PT'S EXTENSION WAS EXPLANTED AND REPLACED AS A RESULT, THEREBY RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219214 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3847816

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention