BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 9130778 · Received September 27, 2019

    Report

    Report Number
    1627487-2019-10987
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    February 7, 2024
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07/07/2023-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION OBTAINED THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 22 JUNE 2023. FSCA NUMBER IS PENDING.

    Additional Manufacturer Narrative · 0

    T WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE FOLLOWING AN MRI. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    H9 - FSCA NUMBER CORRECTED.

    Description of Event or Problem · 0

    BASED ON INFORMATION OBTAINED THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 22 JUNE 2023. FSCA NUMBER IS PENDING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE PROPER PACKAGING AND STERILITY. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE FOLLOWING AN MRI. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924587 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 5869983 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other