BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET TIP

    MDR report key: 2131762 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00921
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K832099
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT UNDER CONCLUSION. EVALUATION SUMMARY: (B)(4): THE LEAD WAS RETURNED AND ANALYZED AND THE PRIMARY FINDING WAS THE OUTER TUBING INSULATION WAS BREACHED METAL ION OXIDIZATION. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. IN ADDITION THE HELIX WAS DISTORTED/BENT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE LEAD WAS RETURNED AND ANALYZED AND THE PRIMARY FINDING WAS THE OUTER TUBING INSULATION WAS BREACHED METAL ION OXIDIZATION. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. IN ADDITION THE HELIX WAS DISTORTED/BENT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE ATRIAL LEAD THAT WAS ABANDONED WAS REMOVED DUE TO INFECTION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4512 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 4470 COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4512 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5024 IMPLANTABLE PACING LEAD| 4470 COMPETITOR IMPLANTABLE PACING LEAD| 5024 IMPLANTABLE PACING LEAD