BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS FLEX EXTN KIT, 60CM, B

    MDR report key: 18503787 · Received January 12, 2024

    Report

    Report Number
    1627487-2024-00267
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 13, 2023
    Report Date
    February 7, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030351
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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

    ADDITIONAL COMPONENT POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS LEAD EXTENSION, MODEL: 6372, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6904575.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENT'S EXTENSIONS WAS DAMAGED BY THE PHYSICIAN DURING A PROCEDURE INTENDED TO REPLACE THE PATIENT'S IPG ON (B)(6)2023. THE DAMAGED EXTENSION WAS INSERTED INTO THE NEW IPG AND THE SURGERY WAS COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE EXTENSIONS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692938 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY ABBOTT MEDICAL 6372 6904575 05415067030351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other BURR HOLE CAP (X2).| DBS IPG (X1).| DBS LEAD (X2).| DBS LEAD EXTENSION (X1).