BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1792667 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07052
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    April 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    KN
    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 SUMMARYMET EXPECTED LONGEVITY. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS WERE ATTACHED/STUCK IN THE HEADER. THE LEADS COULD NOT BE REMOVED FROM THE HEADER. THE PHYSICIAN CUT THE LEADS BY SCISSORS. THE LEADS WERE EXPLANTED AND REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT STATUS IS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention