BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16850149 · Received May 1, 2023

    Report

    Report Number
    1627487-2023-02003
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 11, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 3 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7113412; COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6367638.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS HAD HIGH IMPEDANCES. AS A RESULT THE PATIENT LOST EFFECTIVE THERAPY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712527 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A AB2283 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other DRG IPG.