BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 22048880 · Received May 19, 2025

    Report

    Report Number
    1627487-2025-02468
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 5, 2025
    Report Date
    May 19, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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 EVENT IS CONSISTENT WITH THE BATTERY REACHING END OF LIFE.

    Description of Event or Problem · 0

    IPG EOL: ON (B)(6) 2025, REP (B)(6) EMAILED NMD COMPLAINTS TO REPORT PATIENT'S IPG REACHED EOL APPROXIMATELY ONE MONTH AGO. DR. (B)(6) WILL BE REPLACING HIS NONFUNCTIONAL IPG ON (B)(6) 2025. UPDATES TO FOLLOW. DR. (B)(6). PS DATE: (B)(6) 2025. PPG COMPLAINT HISTORY REVIEW: (B)(6) 2025, (B)(6): COMPLAINT HISTORY SEARCH FOR THE LAST 4 YEARS FOUND PRIOR REPORT(S) ON THIS PATIENT: NONE IT WAS REPORTED PATIENT'S IPG REACHED END OF LIFE. IT WAS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050823 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3660 8273061 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD.