BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 20679786 · Received November 13, 2024

    Report

    Report Number
    3006705815-2024-08639
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    END OF LIFE. ON 23OCT2024, REP (B)(6) EMAILED NMD COMPLAINTS TO REPORT: CHANGED BATTERY DUE TO EOL. FROM P5 TO PP7 DUE TO BETTER DEVICE LONGEVITY. PTS WEIGHT 136.7 KG. PS DATE:23OCT2024. PPG COMPLAINT HISTORY REVIEW: 23OCT2024, A.SALEM: COMPLAINT HISTORY SEARCH FOR THE LAST 4 YEARS FOUND PRIOR REPORT(S) ON THIS PATIENT: NONE IT WAS REPORTED PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223202 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000113756 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD