BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2121793 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07823
    Event Type
    Injury
    Date Received
    June 13, 2011
    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
    OH, 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 LEAD WAS RETURNED TO THE MANUFACTURER IN SEGMENTS AND ANALYZED. THE OUTER INSULATION WAS BREACHED (ENVIRONMENTAL STRESS CRACKING), ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), AND OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO THE PATIENT HAVING TRICUSPID VALVE SURGERY. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 67 YR Hospitalization| R 5092 IMPLANTABLE PACING LEAD| 7074 IMPLANTABLE PULSE GENERATOR| SSR203 IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD| M7700 MECHANICAL HEART VALVE