BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 20392415 · Received October 7, 2024

    Report

    Report Number
    1627487-2024-11367
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982307. COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982304. A PATIENT EXPERIENCING HIGH IMPEDANCE WAS REPORTED TO ABBOTT. THE PATIENT LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEFT T12 LEAD AND RIGHT S1 LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEADS THAT WERE ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217163 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7982304 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DGR IPG| DRG LEAD X2