BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3152341 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06848
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. IT WAS NOTED THAT THE VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND THE LEAD STRETCHING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD IT DISLODGED. UPON A SECONDARY ATTEMPT TO REPOSITION THE EAD, R-WAVE READING DROPPED AND THRESHOLD INCREASED WITH THE VENTRICULAR ELECTROGRAM (VEGM) SHOWING INTERMITTENT VENTRICULAR SUSTAINED TACHYCARDIA. THE RV LEAD WAS ATTEMPTED TO BE REPOSITIONED A THIRD TIME, HOWEVER THERE WAS NOTED HIGH IMPEDANCE AND HIGH THRESHOLD POSSIBLY DUE TO A SMALL CUT AT THE ANCHORING SLEEVE AREA DURING LEAD EXTRACTION. THE RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252965 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 00077 YR