BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 12675987 · Received October 21, 2021

    Report

    Report Number
    1627487-2021-17857
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    October 13, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR EXPLANT DUE TO INFECTION OF A LEAD REPORTED IN (1627487-2021-17793) ANOTHER LEAD WAS FOUND TO BE MIGRATED AND AS SUCH THIS LEAD WAS ALSO EXPLANTED. PATIENT HAD 4 LEADS AND THE OTHER TWO LEADS WERE ABLE TO PROVIDE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569529 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7868051 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other