BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3160416 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07997
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    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 US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT THERAPY: 5554-45, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2008; 5054-58, IMPLANT DATE: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) AT 4 YEARS AND 9 MONTHS AND IS AT VVI65. EARLY BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD HAD A HIGH IMPEDANCE MEASUREMENT DUE TO A LEAD FRACTURE. THE FRACTURE WAS CONFIRMED BY FLUOROSCOPY. THE PROXIMAL PORTION OF THE LEAD WAS EXPLANTED AND THE DISTAL PORTION REMAINED POSITIONED IN THE SUBCLAVIAN VEIN. A NEW LEAD WAS IMPLANTED. THE NEWLY IMPLANTED ATRIAL LEAD DISLODGED. THE LEAD WAS EXPLANTED 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
    259331 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR