BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17263404 · Received July 5, 2023

    Report

    Report Number
    1627487-2023-03119
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 10, 2023
    Report Date
    October 6, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 4 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: SLIM TIP LEAD, MODEL: MN10450-50A, SERIAL: (B)(6), UDI: (B)(4), BATCH: 8081985; COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, SERIAL: (B)(6), UDI: (B)(4), BATCH: 8145749; COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, SERIAL: (B)(6), UDI: (B)(4), BATCH: 8145749.

    Additional Manufacturer Narrative · 0

    THE REPORT OF INEFFECTIVE STIMULATION WAS CONFIRMED. ANALYSIS OF THE LEAD A FOUND THAT IT WAS RETURNED IN TWO SEGMENTS AS A RESULT OF THE EXPLANT PROCEDURE. MICROSCOPIC INSPECTION OF THE STIMULATION END SEGMENT FOUND A KINK ON THE OUTER TUBING WHERE ALL INTERNAL WIRES WERE BROKEN. THESE FRACTURES ARE CONSISTENT WITH AN OVERSTRESS CONDITION OR SUDDEN EVENT THE LEAD WAS SUBJECTED TO WHILE STILL IN VIVO. NO EVALUATION FORM USED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930929 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN20450-50A 8145749

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG| DRG LEAD (X3)