BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19418604 · Received May 29, 2024

    Report

    Report Number
    1627487-2024-09035
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 1 OF 2 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 LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH: 8081987. 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

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-08654. IT WAS REPORTED THAT DURING THE PATIENT'S EXPLANT PROCEDURE THE LEFT LEAD WAS CUT AND LEFT IMPLANTED IN THE PATIENT. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660416 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8081987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG| DRG LEAD