BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2961178 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-02147
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02148. IT WAS REPORTED THE PT WAS UNABLE TO TURN ON HER STIMULATION. DIAGNOSTIC TESTING SHOWED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACT. THE PT REPORTED THE ISSUE BEGAN AFTER SHE FELL IN HER BATHROOM AND HIT HER IPG ON THE SIDE OF HER BATHTUB. FOLLOW-UP INDICATED X-RAYS WERE INCONCLUSIVE AND THE INVALID IMPEDANCE ISSUES PERSIST. IT WAS REPORTED THE PT WAS REFERRED TO A NEUROSURGEON AND SURGICAL INTERVENTION WILL LIKELY BE UNDERTAKEN TO RESOLVE THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39265 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3546974

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SCS ANCHOR: MODEL 1192| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE: