BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 2813066 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17215
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD WAS STRETCHED. IT WAS FURTHER NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED. THE DISTAL AND PROXIMAL CONDUCTORS WERE PULLED, STRETCHED AND OVERSTRESSED. BLOOD COVERED THE DISTAL ELECTRODE. IT WAS VISUALLY NOTED THAT THE LEAD WAS DAMAGED AT IMPLANT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD WAS PLACED IN THE VENTRICLE AND THE LEAD WAS UNABLE TO BE MOVED BY THE PHYSICIAN. THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD AND THE PHYSICIAN HAD DIFFICULTY REMOVING THE LEAD. WHEN THE LEAD WAS EXTRACTED IT WAS NOTED THAT THE HELIX WAS DEPLOYED AND THE PHYSICIAN WAS WORRIED ABOUT THE LEAD MECHANISM AS THE PHYSICIAN HAD NOT DEPLOYED THE HELIX. THE LEAD WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD WAS PLACED IN THE VENTRICLE AND THE LEAD WAS UNABLE TO BE MOVED BY THE PHYSICIAN. THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD AND THE PHYSICIAN HAD DIFFICULTY REMOVING THE LEAD. WHEN THE LEAD WAS EXTRACTED IT WAS NOTED THAT THE HELIX WAS DEPLOYED AND THE PHYSICIAN WAS WORRIED ABOUT THE LEAD MECHANISM AS THE PHYSICIAN HAD NOT DEPLOYED THE HELIX. THE LEAD WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other