BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3153488 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06030
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD WAS RECEIVED WITH THE HELIX OVER RETRACTED, AND DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE IS-1 CONNECTOR. THIS IS INDICATIVE OF THE CONNECTOR PIN BEING TURNED AN EXCESSIVE NUMBER OF TIMES DURING HELIX RETRACTION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT ATRIAL (RA) LEAD HELIX WOULD NOT DEPLOY AFTER SEVERAL ATTEMPTS. THE RA LEAD HELIX DID SUCCESSFULLY DEPLOY WITH THE FIRST ATTEMPT TO PLACE THE LEAD, HOWEVER THE MEASURED VALUES WERE NOT ACCEPTABLE FOR THAT LOCATION IN THE ATRIUM, SO THE HELIX WAS RETRACTED AND THE LEAD REPOSITIONED BUT THEN IT WAS UNABLE TO REDEPLOY THE HELIX. THE RA LEAD WAS REMOVED AND THE HELIX WAS UNABLE TO DEPLOY WHEN THE LEAD WAS OUTSIDE OF THE BODY AND ON THE TABLE. A NEW RA 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
    257736 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR