BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2831903 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-02657
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    August 13, 2012
    Report Date
    October 20, 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

    RESULTS: THE COMPLAINT FOR "INEFFECTIVE STIMULATION" AND "DAMAGE" WAS CONFIRMED. INSPECTION OF THE RETURNED PENTA LEAD SEGMENTS REVEALED EXPOSED WIRES ON THE LEAD PADDLE CONSISTENT WHILE THE LEAD WAS IMPLANTED. THE LEAD WAS CUT APPROXIMATELY 26 CM FROM THE TERMINAL END CONSISTENT WITH EXPLANT DAMAGE. DUE TO THE INCOMPLETE LEAD, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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 PATIENT EXPERIENCED INEFFECTIVE STIMULATION COVERAGE AND ELECTED TO HAVE HER SYSTEM EXPLANTED. IT WAS REPORTED THE PHYSICIAN NOTED THE LEAD WIRES WERE EXPOSED DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3315571

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788