BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2121807 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07824
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND FOUND THE OUTER INSULATION BREACHED, ENVIRONMENTAL STRESS CRACK (ESC). ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER INSULATION HAD COSMETIC METAL INDUCED OXIDATION (MIO), OUTER INSULATION HAD COSMETIC ESC, THE HELIX/LOBE WAS DISTORTED/BENT, AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    THE RIGHT ATRIAL LEAD WAS RETURNED WITH NO INFORMATION, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. INFORMATION WAS RECEIVED INDICATING THE LEAD HAD BEEN REMOVED DUE TO INFECTION. NO FURTHER 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 82 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD