BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3032301 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-13470
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 7, 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
    UT, 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

    THE PT REPORTED HE WAS UNABLE TO TURN ON HIS STIMULATION. HE STATED WHEN HE PRESSES THE "+" BUTTON, THE AMPLITUDE BAR APPEARED, BUT THEN IT AUTOREDUCED. A SYSTEM DIAGNOSTICS TEST DISCOVERED INVALID IMPEDANCES ON CONTACTS 1-8. REPROGRAMMING WAS UNABLE TO CAPTURE STIMULATION AROUND THE INVALID CONTACTS. THE PT UNDERWENT A PROCEDURE AND HIS LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE PT WAS RECEIVING EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131284 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3874035

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT DATE: