BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3961161 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-03476
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 ONLY RECEIVING RIGHT SIDE STIMULATION. DIAGNOSTICS REVEALED INVALID IMPEDANCE VALUES FOR THE SCS LEAD. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A FALL A FEW MONTHS AGO. HOWEVER, AT THE TIME THERE WAS NO CHANGE IN STIMULATION. THE PATIENT IS CONSULTING WITH THE PHYSICIAN REGARDING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413197 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3252464

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS IPG: MODEL 3716| IMPLANT DATE: