BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 2964769 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01550
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 29, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. IT WAS NOTED THAT THE DISTAL ELECTRODE END WAS COVERED INBLOOD. THE GUIDE TOOTH FIXATION WAS DAMAGED. VISUALLY IT WAS NOTED THAT THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER IMPLANT, THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE RA LEAD WAS REPOSTIONED, BUT A FEW HOURS LATER IT DISLODGED A SECOND TIME. THE RA LEA WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66970 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 Hospitalization| R