BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3864720 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07553
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: A2DR01 IPG, IMPLANTED: (B)(6) 2014.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT "I WENT IN FOR MY SECOND DEVICE CHECK, THEY SAID THERE WAS A PROBLEM WITH ONE OF THE LEADS." THE PATIENT ALSO NOTED FEELING SPASMS ON THE RIGHT SIDE OF THE STOMACH, AND THAT THE DOCTOR "TURNED IT DOWN AS LOW AS HE COULD." THE PATIENT ALSO NOTED HAVING VOCAL CORD PARALYSIS. THE PATIENT NOTED A LEAD REVISION WAS IMMINENT. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. BOTH LEADS REMAIN 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
    337748 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 5086MRI58 LEAD