BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19697868 · Received July 8, 2024

    Report

    Report Number
    1627487-2024-09731
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027368
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: REVIEW DHR, ASSOCIATED NCMR / REWORKS, AND DOCUMENT CONCLUSION. DEVICE HISTORY RECORD (DHR) FOR WORK ORDER # (B)(4)., SERIAL # (B)(6), PART # 600026448 (50CM SLIMTIP IMPLANT LEAD KIT, EU, ABT), BATCH # 8372293, AND MODEL MN20450-50A WAS REVIEWED. THERE WERE NO ANOMALIES FOUND THAT WOULD BE RELATED TO THE ALLEGATION. ACCORDING TO THE DHR, THIS WORK ORDER WAS COMPRISED OF TWO BATCHES (8220769 AND 8220884) OF THE LEAD, 50CM SLIM TIP LEAD WITH MARKER, PART # AD1671. ACCORDING TO THE RECEIVING INSPECTION RECORDS FOR BATCHES 8220769 AND 8220884, THE LEADS MET ALL CUSTOMER DRAWING SPECIFICATIONS PER AD1671. RECEIVING INSPECTIONS PERFORMED AQL SAMPLING AND BATCHES WERE ACCEPTED PER SPECIFICATIONS. AS THESE UNITS ARE SENT TO AN OUTSIDE VENDOR TO APPLY THE MARKER, THE BATCHES ARE TRACED THROUGH OUR ENTERPRISE RESOURCE PLANNING SOFTWARE TO THE BATCHES (8134451 AND 8148846) OF THE LEAD ASSY., SLIM TIP, 50CM, PART # AD1667 THAT WAS BUILT ON WORK ORDERS (B)(4). ACCORDING TO THE DHR¿S PART # AD1667 HAD BEEN MANUFACTURED AND TESTED ACCORDING TO CURRENT MANUFACTURING SPECIFICATIONS. UNITS OF BATCHES 8134451 AND 8148846 OF PART # AD1667 THAT WERE RELEASED INTO COMPONENT GOODS PASSED ALL MANUFACTURING VISUAL INSPECTION AND ELECTRICAL TESTING REQUIREMENTS. THE REPORT EVENT OF HIGH IMPEDANCES WAS CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION SHOWED THE RETURNED LEAD FOUND A KINK ON TUBING AND ALL THE INTERNAL LEAD WIRES BEING BROKEN."

    Additional Manufacturer Narrative · 0

    REPORTER PHONE NUMBER (B)(4). B3-DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ONE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256955 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN20450-50A 8372293 05415067027368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other