BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2963518 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02195
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PRODUCT: 4193 IMPLANTABLE PACING LEAD (B)(6) 2005, 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005, 5076 IMPLANTABLE PACING LEAD (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS SHORTER THAN EXPECTED DUE TO HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP DETERMINED IT WAS THE LEFT VENTRICULAR LEAD WHICH HAD THE HIGH THRESHOLD DUE TO A POSITIONING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66338 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR