BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15442322 · Received September 16, 2022

    Report

    Report Number
    1627487-2022-04966
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 16, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020857
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. REPORTER PHONE NUMBER: (B)(6). ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: 8CH SJM INF COILED EXT KIT, 60 CM BLACK, MODEL: 6372, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7173585. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED HIGH IMPEDANCES ON THE EXTENSION. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEAD EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD EXTENSION HAD HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177610 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B DBS EXTENSION MHY ABBOTT MEDICAL 6372 7173585 05415067020857

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other DBS EXTENSION| DBS IPG