BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3141236 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-06342
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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 EFFECTIVE STIMULATION COVERAGE COULD NOT BE OBTAINED DURING POST-OPERATIVE PROGRAMMING. X-RAYS WERE TAKEN AND IT WAS FOUND THE PT'S LEAD HAD MIGRATED. ON (B)(6) 2013, THE PT UNDERWENT SURGICAL INTERVENTION TO REPOSITION THE LEAD, HOWEVER, THE PHYSICIAN REPORTED HE WAS UNABLE TO PLACE THE LEAD IN THE CORRECT LOCATION. EFFECTIVE COVERAGE WAS NOT CAPTURED POST-OPERATIVE. F/U WITH AN SJM REP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231030 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3861993

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788