BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3152550 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06751
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    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 PRODUCTS: A3DR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2013; 5086 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED OF CHEST PAIN. A COMPUTED TOMOGRAPHY SCAN CONFIRMED THE RIGHT VENTRICULAR (RV) LEAD HELIX HAD DISLODGED ALONG WITH LEAD PERFORATION. A LEAD REVISION WAS PERFORMED. THE PHYSICIAN FELT THERE WAS A PROBLEM WITH LEAD MANEUVERABILITY. THE THRESHOLD MEASUREMENT ON THE RV LEAD WAS HIGH. THE LEAD WAS REPOSITIONED AND REMAINS 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
    252081 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| L| R