BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3863180 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06585
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CONCOMITANT PRODUCT: 5086MRI52 LEAD IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT BACTEREMIA WITHOUT AN IDENTIFIABLE SOURCE AND THERE WAS CONCERN THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD BE PLAYING A ROLE IN THE INFECTION. THE IPG SYSTEM WAS EXPLANTED. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339042 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 00061 YR Hospitalization| R A2DR01 IPG