BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3993969 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09037
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY IMPEDANCE HAD INCREASED AND RESULTED IN THE REPLACEMENT OF THE DEVICE. DURING THE DEVICE RE PLACEMENT PROCEDURE THE PHYSICIAN OPENED THE POCKET AND REMOVED THE DEVICE, THE VENTRICULAR LEAD WAS DISCONNECTED, AND THE PSA MEASUREMENT WAS ATTEMPTED, HOWEVER AFTER CONNECTING AN ALLIGATOR CABLE THERE WAS NO SENSING. DESPITE THE REPLACEMENT OF THE PSA CABLE AND THE ALLIGATOR CLIP CABLE, A SENSING VALUE COULD NOT BE OBTAINED, LOW LEAD IMPEDANCE, AND INTERMITTENT FAILURE TO CAPTURE THE HEART/PACE AT THE MAXIMUM OUTPUT. THE LEAD INTEGRITY WAS CHECKED BY X-RAY AND CONFIRMED A LEAD FRACTURE NEAR THE POCKET AND THE PHYSICIAN INDICATED THAT THE LEAD WAS POSSIBLY CUT DURING THE OPENING OF THE POCKET. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470924 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| R KSR901J IPG