BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4223248 · Received October 29, 2014

    Report

    Report Number
    1627487-2014-05742
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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 INFO 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

    IT WAS REPORTED THE PATIENT HAS BEEN UNABLE TO RECEIVE EFFECTIVE STIMULATION. IT WAS ALSO REPORTED THE PATIENT HAD BEEN IN A CAR ACCIDENT ON (B)(6) 2013. THE PATIENT'S DOCTOR BELIEVES THE AUTOMOBILE ACCIDENT MAY HAVE CAUSED THE STIMULATION ISSUE. REPROGRAMMING ATTEMPTS TO PROVIDE RESOLUTION WERE UNSUCCESSFUL. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. FOLLOW-UP REVEALED THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691257 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3704909

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3788,