BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 12221591 · Received July 23, 2021

    Report

    Report Number
    3006705815-2021-03589
    Event Type
    Death
    Date Received
    July 23, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. BASED ON THE INFORMATION PROVIDED, A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15837. IT WAS REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2021 FOLLOWING A SYSTEM REPLACEMENT SURGERY ON (B)(6) 2021 TO ADDRESS AN INEFFECTIVE THERAPY ISSUE. (REFERENCE REG REPORT: 1627487-2021-13844, 3006705815-2021-03060). NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118777 PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000106748 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 Death