BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1875300 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11688
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY; (B)(4) THE PROXIMAL SEGMENT WAS RETURNED WHERE IT WAS DISCOVERED THAT THE INNER INSULATION WAS BREACHED DUE TO METAL ION OXIDATION, THERE WAS BLOOD ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD MELTED AND WAS BREACHED CUT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE DEVICE WAS RETURNED WITHOUT INFORMATION REGARDING PATIENT IMPACT OR PRODUCT PERFORMANCE. EFFORTS TO CONTACT THE PHYSICIAN/HOSPITAL REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL. 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 84 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5024 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD