BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3961053 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-08111
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    September 5, 2013
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    IT WAS REPORTED THE PT'S SCS SYS STIMULATION WAS INEFFECTIVE IN COVERING HER PAINFUL AREAS BEGINNING ON (B)(6) 2013. THE PT HAD MULTIPLE FALLS AROUND THE TIME IN WHICH STIMULATION BECAME INEFFECTIVE. AN SJM REP MET WITH THE PT AND WAS ABLE TO REPROGRAM THE PT'S SYS FOR EFFECTIVE STIMULATION. ADDITIONAL INFO RECEIVED ON (B)(6) 2013 INDICATED X-RAYS PREVIOUSLY TAKEN INDICATED POSSIBLE LEAD MIGRATION BUT REPROGRAMMING WAS ABLE TO PROVIDE STIMULATION IN NEEDED AREAS. ADDITIONAL INFO RECEIVED ON (B)(6) 2014 IDENTIFIED THE PT WAS SCHEDULED TO MEET WITH HER SURGEON TO DISCUSS A POSSIBLE REVISION. PT'S SURGEON ORDERED X-RAYS TO FURTHER EVALUATE THE SYS. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413198 PENTA SCS LAED GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3861993

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788