BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR

    MDR report key: 19342627 · Received May 17, 2024

    Report

    Report Number
    1627487-2024-08785
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    May 24, 2021
    Report Date
    January 3, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020260
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487-05/17/24-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE FSCA NUMBER IS PENDING. REPORTER PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    THE REPORT OF INOPERABLE IPG WAS CONFIRMED. ANALYSIS OF THE RETURNED IPG FOUND THAT THE CAUSE OF THE REPORTED OBSERVATION WAS DUE TO THE DEVICE HAVING NORMAL BATTERY DEPLETION TO THE END OF LIFE (EOL). THIS COMPLAINT WAS IDENTIFIED IN HHE 2024-015 COMPLAINT REVIEW FOR LATE ERI NOTIFICATION FOR ORION IPGS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REPORT OF INOPERABLE IPG WAS CONFIRMED. ANALYSIS OF THE RETURNED IPG FOUND THAT THE CAUSE OF THE REPORTED OBSERVATION WAS DUE TO THE DEVICE HAVING NORMAL BATTERY DEPLETION TO THE END OF LIFE (EOL). THIS COMPLAINT WAS IDENTIFIED IN (B)(4) COMPLAINT REVIEW FOR LATE ERI NOTIFICATION FOR ORION IPGS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION. FURTHER ANALYSIS FOUND THAT THE IPG DID NOT MEET THE CALCULATED NUMBER OF EXPECTED DAYS BETWEEN THE OCCURRENCE OF ERI AND THE OCCURRENCE OF EOS

    Description of Event or Problem · 0

    UPON RETROSPECTIVE REVIEW, THE PATIENT LOST THERAPY DUE TO DEVICE REACHING END OF SERVICE (EOS) FROM ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED AND REPLACEMENT SURGERY WAS REQUIRED TO RESTORE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531032 INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR DBS IPG MHY ABBOTT MEDICAL 6662 6563209 05415067020260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other