BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2813616 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17034
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    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 AN ATRIAL LEAD WARNING WAS TRIGGERED DUE TO LOW IMPEDANCE. UNIPOLAR IMPEDANCE IS HIGHER THAN BIPOLAR IMPEDANCE AND AN AUTO POLARITY SWITCH WAS NOTED UPON ROUTINE INTERROGATION. IT WAS ALSO REPORTED THAT THE VENTRICULAR LEAD SHOWED SIGNS OF IMPEDANCE DECLINE AND POSSIBLE EARLY INSULATION BREACH. THE DEVICE WAS REPROGRAMMED AND THE LEADS REMAIN IN USE. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention KDR901 IMPLANTABLE PULSE GENERATOR