BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1926559 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14394
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4) NO ANOMALIES FOUND (B)(4) PROXIMAL SEGMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO CHANGE THE PATIENT TO A SINGLE CHAMBER DEVICE THAT IT WAS NOTED THAT THE ATRIAL LEAD SHOWED INSULATION FAILURE. THE LEAD WAS ALSO NOTED TO HAVE LOW IMPEDANCE AND AN APPARENT CONDUCTOR FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R 5024M IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR