BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3153672 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06159
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCTS: (B)(4) IMPLANTABLE PACING LEAD 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS DISLODGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK POST IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT WAS SYMPTOMATIC WITH DIZZINESS. IT WAS FOUND THAT THERE WAS EXIT BLOCK MANIFESTED AS HIGH CAPTURE THRESHOLD WITH NONCAPTURE. THE LEAD WAS REPOSITIONED, HOWEVER TWO LOCATIONS WERE ATTEMPTED BEFORE ADEQUATE SENSING AND PACING THRESHOLDS WERE OBTAINED. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY 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
    256456 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 00074 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)