BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE FIX

    MDR report key: 3153541 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06084
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CONTINUED: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2013; A2DR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF CHEST PAIN AND TEST RESULTS SHOWED EFFUSION. IT WAS SUSPECTED THAT THE RIGHT ATRIAL (RA) LEAD MAY HAVE PERFORATED THE HEART. THE RA LEAD WAS REVISED AND IT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256887 CAPSURE FIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R