BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1990325 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01937
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A 970 LOW IMPEDANCE PACES POST ATRIAL LEAD WARNING, WHICH OCCURRED ON (B)(4)-2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXPERIENCED LOW AND VARIABLE IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS A CONCERN REGARDING THE VENTRICULAR LEAD DUE TO SHORT AND IRREGULAR INTERVALS OBSERVED IN A VENTRICULAR HIGH RATE EPISODE, AND ITS IMPEDANCE HAD DECREASED. AN ATRIAL HIGH RATE EPISODE ALSO SHOWED NOISE ON THE LEADS. BOTH ATRIAL AND RIGHT VENTRICULAR 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 Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR