BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17999828 · Received October 24, 2023

    Report

    Report Number
    1627487-2023-05049
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT EVENT OF SLIM TIP BROKEN WAS NOT CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION SHOWED THE RETURNED LEAD SLIM TIP NO ANOMALIES/DAMAGE WAS FOUND. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. THE REPORT EVENT OF HIGH IMPEDANCES WAS NOT CONFIRMED. AS RECEIVED, ELECTRICALLY TESTED SHOWED THE RETURNED BOTH TERMINAL ENDS SEGMENTS WERE PASSED ISOLATION RESISTANT TESTING. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN."

    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: 8830806. COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8892605.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN, THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. ATTEMPTS TO REPROGRAM WERE UNSUCCESSFUL. IMAGING SHOWED THAT ONE LEAD WAS BROKEN. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567409 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN20450-50A 8472785

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG LEAD X2