BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 5468023 · Received February 29, 2016

    Report

    Report Number
    3006705815-2016-00076
    Event Type
    Injury
    Date Received
    February 29, 2016
    Date of Event
    November 24, 2015
    Report Date
    March 8, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2016-00944. FOLLOW-UP INFORMATION REVEALED DURING INTER-OP, DIAGNOSTIC TESTING REVEALED THE PATIENT'S LEAD REFLECTED NORMAL IMPEDANCE READINGS. IT WAS ALSO REPORTED THE PATIENT'S LEAD HAD MIGRATED; THEREFORE, THE PHYSICIAN INSERTED A STYLET AND ATTEMPT ED TO REPOSITION THE PATIENT'S EXISTING LEAD. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. AS SUCH, THE PHYSICIAN THEN INSERT ED AN ADDITIONAL LEAD, BUT EFFECTIVE STIMIULATION COULD NOT BE ACHIEVED (REPORTED UNDER MFR. REPORT#: 1627487-2016-01655). AS A RESULT, THE PHYSICIAN EXPLANTED THE PATIENT'S ENTIRE SCS SYSTEM.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2016-00944. IT WAS REPORTED THE PATIENT FEELS STIMULATION IN THE INCORRECT LOCATION AND WHEN STIMULATION IS INCREASED, THE PATIENT FEELS UNWANTED STIMULATION IN THE UPPER BUTTOCK AND LOWER BACK . THE PATIENT'S TARGETED AREA OF PAIN IS THE RIGHT FOOT, ANKLE, AND SHIN. IT WAS NOTED THE PATIENT ORIGINALLY HAD EFFECTIVE STIMULATION COVERAGE FOLLOWING THE PERMANENT IMPLANT. HOWEVER, THERAPY DIMINISHED SHORTLY THEREAFTER. IN ADDITION, IT WAS REPORTED THE PATIENT'S IPG IS PULLING. SUBSEQUENTLY, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125703 PROTÉGÉ MRI IPG SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5219696

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR