BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 2955192 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00840
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION HAD CLAVICLE/RIB CRUSH. THE PROXIMAL AND DISTAL CONDUCTORS WERE KINKED, BUCKLED; THE DISTAL CONDUCTOR WAS OVER ROTATED. THE OUTER INSULATION HAD COSMETIC CLAVICLE RIB CRUSH. AND THERE WAS BLOOD INGRESSION IN THE OUTER INSULATION. IT WAS ALSO NOTED THAT THE HELIX WOULD NOT EXTEND OR RETRACT DUE TO THE DISTAL CONDUCTOR BEING DISTORTED WITH THE CONNECTOR.

    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 THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD A LOSS OF PACING. FLUOROSCOPY SHOWED THAT THE RV LEAD HAD MIGRATED. A LEAD REPOSITIONING WAS PLANNED, AND WHILE ATTEMPTING TO REPOSITION THE RV LEAD, THE HELIX WOULD NOT RETRACT. THE RV LEAD WAS EXPLANTED AND A NEW RV LEAD IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58085 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R