BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3152591 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06744
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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

    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 AT THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD HELIX EXTENDED ON THE TABLE AFTER APPROXIMATELY 40 TURNS THEN RETRACTED AFTER ABOUT 10 TURNS. THE LEAD WAS ATTEMPTED TO BE IMPLANTED BUT HAD TO BE REPOSITIONED 3 TIMES DUE TO HIGH IMPEDANCE. FLUOROSCOPY APPEARED CLEAR THAT THE HELIX WAS EXTENDING AND RETRACTING. THE RV LEAD WAS REMOVED FROM THE BODY AND THE HELIX WOULD NOT EXTEND. IT WAS FURTHER REPORTED THAT BEFORE THE ATRIAL LEAD WAS PLACED IN THE BODY, AN ATTEMPT WAS MADE TO EXTEND THE HELIX BUT IT WOULD NOT EXTEND. BOTH LEADS WERE NOT IMPLANTED AND OTHER LEADS WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252120 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 00079 YR