BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 20687778 · Received November 14, 2024

    Report

    Report Number
    1627487-2024-11997
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    September 20, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. THE REPORT OF ¿INEFFECTIVE THERAPY¿ WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED LEAD A FOUND IT WAS CUT INTO SEGMENTS DURING EXPLANT. CONTINUITY WAS CHECKED FROM CONTACTS TO CORRESPONDING BARE WIRES, AND NO OPENS WERE FOUND. 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 · 0

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEADS, AND UPON FURTHER INVESTIGATION, THE PATIENT'S LEADS HAD FRACTURED. AS A RESULT, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024, DURING SURGERY THE L3 LEAD WAS SERVED, AND UNABLE TO BE REMOVED (PER-2024-0173270), BUT THE REST OF THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350424 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7791320 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other DRG IPG