BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1862828 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10525
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    April 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTRICULAR LEAD WARNING WAS TRIGGERED AND THE POLARITY SWITCHED TO UNIPOLAR. LOW IMPEDANCES WERE NOTED PRIOR TO THE MODE SWITCH. FOLLOWING THE MODE SWITCH, OVERSENSING AND NOISE WERE OBSERVED. THE LEAD REMAINS IMPLANTED AND WAS LEFT IN UNIPOLAR MODE. 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. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other ADDRL1 IMPLANTABLE PULSE GENERATOR| 4558M IMPLANTABLE PACING LEAD