BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1875319 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11659
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    June 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN PART ON DEVICE RETURN AND ANALYSIS (RIGHT ATRIAL LEAD). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, HOWEVER OUTER INSULATION BREACHED CUT; FULL LEAD RETURNED AND ANALYZED. (B)(4): INNER INSULATION BREACHED AND BLOOD NOTED ON HELIX MECHANISM; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT DURING DEVICE CHANGEOUT DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR), BOTH THE RIGHT ATRIAL AND VENTRICULAR LEADS WERE NOTED TO BE DETERIORATING AND SO WERE EXPLANTED AND REPLACED. 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 SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR