BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3578202 · Received October 29, 2013

    Report

    Report Number
    1627487-2013-21241
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS RECEIVING INEFFECTIVE LOW BACK STIMULATION. AS A RESULT, THE PATIENT HAS NOT BEEN USING HIS SYSTEM AND WANTS TO HAVE IT EXPLANTED. FOLLOW-UP IDENTIFIED THE PATIENT IS ALSO CONSIDERING AN MRI SINCE THE PHYSICIAN WANTS TO EVALUATE HIS CERVICAL AREA. THE PATIENT WAS GIVEN NEW STIMULATION PROGRAMS TO TRY PRIOR TO DETERMINING THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555809 PENTA GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3365313

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANT:| GZB: MODEL 3788