BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 8724630 · Received June 21, 2019

    Report

    Report Number
    1627487-2019-06637
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 1, 2019
    Report Date
    July 10, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    A CASE OF HEMATOMA AND PAIN AT IPG SITE WAS REPORTED TO ABBOTT. THE HEMATOMA HAS SETTLED AND THERE IS NO SIGN OF IT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND RETURNED TO THE PHYSICIAN FOR EVALUATION ON (B)(6) 2019. IT WAS DISCOVERED THE PATIENT HAD A HEMATOMA AT THE IPG SITE, AND BLOODWORK WAS UNREMARKABLE FOR INFECTION. ICE PACKS WERE USED TO HELP ALLEVIATE THE HEMATOMA. FOLLOW UP REVEALED THE PATIENT¿S HEMATOMA HAD SETTLED DOWN, AND ONLY A FAINT BRUISING REMAINED. THE PATIENT FEELS DISCOMFORT AROUND THE IPG AND LEAD SITE WHEN STIMULATION IS ON, AND THE PHYSICIAN ATTRIBUTES THIS TO POSSIBLY BEING CAUSED BY THE FLUID FROM THE HEMATOMA AROUND THE AREA.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION IDENTIFIED THE HEMATOMA HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517797 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 6659513 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other