BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1925789 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14059
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REPLACED DUE TO CHRONIC HIGH LEAD IMPEDANCES. DURING THE REPLACEMENT PROCEDURE A 4076 LEAD WAS ATTEMPTED IMPLANTED BUT NOT USED AS THE PHYSICIAN BELIEVED THE PATIENT'S TIGHT ACCESS MAY HAVE CAUSED DAMAGE TO THE LEAD DURING IMPLANT A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5024M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R 4504M IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR