BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER

    MDR report key: 3926231 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-01376
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2012
    Report Date
    May 9, 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'S TRANSMITTER HAS BEEN UNABLE TO COMMUNICATE WITH THE RECEIVER FOR THE PAST TWO YEARS. SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322554 RENEW RECEIVER SCS RECEIVER GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3408 A11001

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other SCS LEAD, MODEL 3186