BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2993987 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-03302
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT IS RECEIVING UNWANTED STIMULATION ON HER LEFT SIDE (PAIN PATTERN IS RIGHT SIDE). X-RAYS IDENTIFIED THE PATIENT'S SCS LEAD HAS MIGRATED. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEAD REVISION IN WHICH THE SCS LEAD WAS MOVED BACK TO ITS ORIGINAL POSITION. THE REVISION WAS UNSUCCESSFUL AS THE PATIENT ONLY FELT STIMULATION IN HER RIGHT SIDE STOMACH AND ABDOMEN. REPROGRAMMING IS TO BE ATTEMPTED. FOLLOW-UP IDENTIFIED A SJM REP WAS UNABLE TO OBTAIN EFFECTIVE STIMULATION WITH REPROGRAMMING. SUBSEQUENTLY, THE PATIENT'S SCS LEAD WAS REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88757 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3780776

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: