BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3060226 · Received April 10, 2013

    Report

    Report Number
    1627487-2013-03495
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 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

    RESULTS: THE COMPLAINT FOR "INVALID IMPEDANCE" COULD NOT BE CONFIRMED FOR THE (3228) PENTA LEAD. AS RECEIVED, THE LEAD WAS COMPLETE AND IN GOOD CONDITION. THE PENTA LEAD PASSED ALL FUNCTION TESTS. SJM HAS LIMITED INFO 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 DURING THE PT'S PERMANENT PROCEDURE, LEAD DIAGNOSTICS SHOWED HIGH/INVALID IMPEDANCE VALUES FOR THE SCS LEAD. SUBSEQUENTLY, THE LEAD WAS REPORT WHICH REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153001 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3861993

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SCS IPG: MODEL 3788| IMPLANTED: