BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3992912 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09601
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT MEDICAL PRODUCTS: 4524-53 LEAD, IMPLANTED: (B)(6) 1994. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTRICULAR LEAD WARNING WAS TRIGGERED DUE TO RIGHT VENTRICULAR (RV) LEAD HIGH THRESHOLDS, LOW PACING IMPEDANCE AND INSULATION DAMAGE AFTER 20 YEARS OF USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS OVERSENSING NOISE AND FAR-FIELD RWAVES (FFRW). BOTH LEADS REMAIN IN USE. THE PHYSICIAN NOTED THAT WHEN A DEVICE CHANGEOUT IS PLANNED, A NEW RV LEAD WILL BE CONSIDERED AT THAT TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468387 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00096 YR SEDR01 IPG