BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1790987 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00421
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    February 17, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S9
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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) ANALYSIS REVEALED THAT THE REPORTED ATRIAL UNDERSENSING WAS THE RESULT OF A LEAKY CERAMIC CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE ATRIAL LEAD AND T-WAVE PACING ON VENTRICULAR. THE DEVICE WAS REPLACED AND THE LEADS REMAIN IMPLANTED. NO FURTHER 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 5524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5024 IMPLANTABLE PACING LEAD