BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 16048643 · Received December 26, 2022

    Report

    Report Number
    3006705815-2022-18887
    Event Type
    Injury
    Date Received
    December 26, 2022
    Date of Event
    July 25, 2018
    Report Date
    February 23, 2023
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. DATE OF EXPLANT IS UNKNOWN. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. THE ALLEGATION IS AGAINST 1 OF 2 IPGS; HOWEVER, IT IS UNKNOWN WHICH IPG, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: EON MINI IPG, MODEL: 3788ANS, SERIAL: (B)(4),, UDI: (B)(4),BATCH: 3143585.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ONE OF THEIR IPGS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653590 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000105442 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other SCS LEAD (X2)| SCS LEAD ANCHOR (X2)| SCS LEAD EXTENSION (X2)