BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 7721021 · Received July 25, 2018

    Report

    Report Number
    1627487-2018-06893
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    April 9, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. 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.

    Additional Manufacturer Narrative · 1

    THE EXPLANT DATE WAS INADVERTENTLY INCLUDED IN THE INITIAL REPORT AS THE DATE WAS NOT REQUIRED DUE TO THE EXISTING DEVICE WAS REPOSITIONED AND NOT EXPLANTED DURING THE PREVIOUSLY REPORTED SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE (DESCRIBED AS A ZAPPING SENSATION BY THE PATIENT ) AS WELL AS DISCOMFORT DUE TO THE IPG ANGLED SUPERFICIAL TO THE SURFACE OF THEIR SKIN. SUBSEQUENTLY, X-RAYS OBTAINED OF THE SCS SYSTEM REVEALED NO ANOMALIES. HOWEVER, THE PHYSICIAN OPTED FOR SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUES. FOLLOW-UP IDENTIFIED THE PROCEDURE WAS UNDERTAKEN ON 02 JULY 2018 WHEREIN THE ORIGINAL IPG POCKET SITE WAS REVISED TO A MORE COMFORTABLE LEVEL FOR THE PATIENT. POSTOPERATIVELY, THERAPY WAS RESTORED WITH SATISFACTORY COVERAGE.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560350 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 6070166 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other