BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR

    MDR report key: 13720370 · Received March 10, 2022

    Report

    Report Number
    1627487-2022-01344
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 26, 2022
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    THE REPORTED OBSERVATION OF ¿IPG INOPERABLE¿ WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED OBSERVATION WAS DUE TO THE DEVICE HAVING NORMAL BATTERY DEPLETION TO THE END OF LIFE (EOL). THE DEVICE PROVIDED THERAPY PER THE PROGRAMMING UP TO THE EOL DECLARATION DATE. (B)(4). THE TOTAL STIMULATION ON TIME WAS 2.2 YEARS, SUGGESTING THE DEVICE HAD NORMAL BATTERY DEPLETION TO THE END OF LIFE. THE DEVICE WAS SUBJECTED TO A FUNCTIONAL TEST ON AUTOMATED TEST EQUIPMENT (ATE). THIS TESTER VERIFIES THE ELECTRICAL PERFORMANCE OF THE CONTROL/COMMUNICATION CIRCUITRY, AND OUTPUT SIGNAL INTEGRITY. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS DURING TESTING. HENCE, THIS EVENT NO LONGER MEETS THE REPORTABILITY CRITERIA.

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS PENDING.

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED OBSERVATION OF ¿IPG INOPERABLE¿ WAS CONFIRMED. THE ROOT 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 REPORTED OBSERVATION OF ¿IPG INOPERABLE¿ WAS CONFIRMED. THE ROOT 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. 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

    IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO THE IPG REACHING END OF LIFE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. THERAPY WAS CONFIRMED POST OP.

    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
    1784836 INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR DBS IPG MHY ABBOTT MEDICAL 6662 7148719 05415067020260

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female DBS EXTENSION (X2)| DBS LEAD (X2)