BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4163357 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12375
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 27, 2014
    Report Date
    July 27, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: 5086MRI58, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT'S IMPLANTED RIGHT ATRIAL (RA) LEAD DISLODGED FOLLOWING THE PROCEDURE. A LEAD REVISION PROCEDURE FOLLOWED, AND THE RA LEAD BECAME DISLODGED A SECOND TIME. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ATTACH THE LEAD TO THE PATIENT'S ANATOMY, BUT WAS UNSUCCESSFUL. THE PHYSICIAN CHOSE TO CAP THE RA LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643540 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 00073 YR Hospitalization| R RVDR01 IPG