BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3990688 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08562
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE PHYSICIAN HAD DIFFICULTY PLAC ING TWO SEPARATE RIGHT VENTRICULAR LEADS, WHICH WERE NOTED TO NOT BE SENSING NOR CAPTURING. PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EFFUSION, AND THE LEADS WERE NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468744 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| L| R