BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2813165 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16249
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND THE INNER INSULATION HAD BREACHED METAL ION OXIDATION (MIO). IT WAS NOTED THAT ALL OF THE CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED AND MELTED, BOTH THE INNER INSULATION AND THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD CHRONICALLY HIGH THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4058M

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR| 4058M IMPLANTABLE PACING LEAD