BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY IPG

    MDR report key: 6914077 · Received October 4, 2017

    Report

    Report Number
    1627487-2017-05776
    Event Type
    Injury
    Date Received
    October 4, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 ((B)(6)) THE PATIENT WAS NOT RECEIVING RELIEF FROM IPG USING BURST. SHE RAN THE STIM ON TONIC FOR 3 DAYS AND REPORTED TIMES WHEN IT WAS NOT WORKING AT ALL AND OTHER TIMES WHEN SHE COULD FEEL SOME STIMULATION BUT NOT AT THE LEVEL AT WHICH IT HAD BEEN SET. IMPEDANCES ARE ALL OK AND DEVICE APPEARED TO BE FUNCTIONING CORRECTLY. PATIENT UNDERWENT EXPLANT OF IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694031 PRODIGY IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3799 5198640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3156, SCS LEAD