BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3153061 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05802
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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 PRIMARY ANALYSIS FINDING NOTED THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE LEAD FIXATION WAS OUT OF SPECIFICATION WITH EXTENDED/RETRACTED HELIX COVERED IN BODY TISSUE/FIBROTIC GROWTH. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. LEAD WAS RETURNED WITH THE HELIX DISTORTED/BENT AND BLOOD AND TISSUE ON IT. ELECTRICAL RESISTANCE AND CROSS CONTINUITY AND HELIX LENGTH TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD UNACCEPTABLE THRESHOLD AND SENSING VALUES. THE LEAD WAS REPOSITIONED SEVERAL TIMES AND WAS, SUBSEQUENTLY, PULLED OUT OF THE SHEATH TO REVEAL TISSUE WAS ATTACHED TO THE HELIX. AFTER THE TISSUE WAS CLEANED OFF, THE HELIX WAS NOTED WITH A BEND. THE LEAD WAS NOT IMPLANTED AND WAS 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
    256175 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 00078 YR