BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2921765 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-02086
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 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
    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 4. REFERENCE MFR REPORTS: 1627487-2013-02087, 1627487-2013-02088 AND 1627487-2013-02089. THE PT HAD A LEAD IMPLANTED IN THE CERVICAL REGION AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT BENT DOWN FROM A SITTING POSITION AND FELT A POP AT THE INCISION SITE ON THE BACK OF HER NECK. SHE STATED HER STIMULATION IMMEDIATELY STOPPED WORKING. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AND DIAGNOSTIC TESTS REVEALED INVALID IMPEDANCE READINGS. FOLLOW-UP INDICATED THE PT UNDERWENT SURGERY ON (B)(6) 2013. THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S EXTENSIONS AND IPG. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19944 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3847820

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention