BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 7757290 · Received August 7, 2018

    Report

    Report Number
    1627487-2018-07251
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    September 13, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED THE ERI MESSAGE ON THEIR EXTERNAL DEVICE AND THE ERI MESSAGE APPEARED ON THE ABBOTT REPRESENTATIVES PROGRAMMER ALSO. THE ABBOTT REPRESENTATIVE UPDATED THE SOFTWARE VERSION; HOWEVER, THE ERI MESSAGE DID NOT CLEAR. IN ADDITION, IT WAS DETERMINED THE IPG WAS INOPERABLE AND IT IS UNKNOWN WHEN THE PATIENT LAST RECEIVED THERAPY. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THE IPG WAS REMOVED AND REPLACED. POSTOPERATIVELY, THERAPY HAS BEEN RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598210 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 5523707 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192 (2), SCS ANCHOR| MODEL 3186 (2), SCS LEAD