BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORION SEF IPG 5.3AH TONIC NONRECHARGEABLE

    MDR report key: 7957445 · Received October 11, 2018

    Report

    Report Number
    1627487-2018-09219
    Event Type
    Injury
    Date Received
    October 11, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT IPG SITE. AS A RESULT, THE PATIENT IS AWAITING SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION PROVIDED THE PHYSICIAN REPOSITIONED THE PATIENT¿S IPG POCKET ABOVE WHERE IT WAS LOCATED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798398 ORION SEF IPG 5.3AH TONIC NONRECHARGEABLE DRG IPG PMP ST. JUDE MEDICAL - NEUROMODULATION 3664 6179446 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other MODEL MN10450-50A (X2), DRG LEAD