BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3993792 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09104
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEAD IMPLANT ATTEMPT, THE LEAD DEMONSTRATED NORMAL HELIX DEPLOYMENT; HOWEVER, WHEN THE LEAD WAS TESTED THERE WAS NOISE, HIGH IMPEDANCE MEASUREMENTS AND NO CAPTURE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BY RETRACTING THE HELIX WITH THE STYLET IN THE LEAD. THE HELIX WOULD NOT RETRACT WITH MULTIPLE COUNTER CLOCKWISE TURNS. THE LEAD BODY WAS COUNTER ROTATED TO RELEASE THE HELIX FROM THE ENDOCARDIUM. IT WAS SUSPECTED THE HELIX MECHANISM BROKE DURING DEPLOYMENT. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468962 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 00060 YR