BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1863395 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11343
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. FULL LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLOOD INGRESS INTO BOTH THE DEVICE CONNECTOR AND LEAD STYLET HOLE. THE DEVICE AND LEAD WERE 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. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention