BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3990291 · Received August 7, 2014

    Report

    Report Number
    3008973940-2014-00286
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF AN IMPLANTABLE PACING LEAD THE PATIENT COMPLAINED OF CHEST PAIN FOLLOWED BY DECLINE OF CONSCIOUSNESS. THERE WAS A DECREASE IN BLOOD PRESSURE AND OXYGEN SATURATION. THE PROCEDURE WAS TERMINATED. CARDIAC MASSAGE WAS PERFORMED AND MEDICATION WAS ADMINISTERED. AN IMPLANTABLE PACING LEAD PERFORATION WAS SUSPECTED. PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT RECOVERED CONSCIOUSNESS, HOWEVER TEMPORARY PACING WAS APPLIED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463738 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI52

    Patients

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