BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 2131903 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10590
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH/UNSTABLE THRESHOLDS, LOW IMPEDANCE, AND UNDERSENSING. THERE WERE ALSO APPARENT OUTER INSULATION BREACHES IN MULTIPLE PLACES. THE LEAD WAS CAPPED AND ANOTHER WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4003 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R 8961IU IMPLANTABLE PULSE GENERATOR