BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3153558 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00069
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. THE ANALYST COMMENTED, THE LEAD WAS RETURNED WITH THE HELIX PARTIAL EXTENDED. THE LEAD WAS RETURNED STRETCHED, WITH BUCKLING OF THE INNER INSULATION. A STRETCHED LEAD MAY NOT FULLY TRANSFER TORQUE TO THE HELIX WHEN TURNING THE IS-1 CONNECTOR PIN.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE RIGHT VENTRICULAR (RV) LEAD WAS POSITIONED, THE HELIX WAS SCREWED OUT AND WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, THE HELIX FAILED TO RETRACT. THE LEAD WAS REMOVED AND A DIFFERENT RV 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
    258563 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR