BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4161728 · Received October 10, 2014

    Report

    Report Number
    3008973940-2014-00366
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    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. CONCOMITANT: 457445 LEAD IMPLANTED: 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS POST-IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE DISLODGED AS NOTED ON AN X-RAY PHOTO OF THE PATIENT'S CHEST. IN ADDITION, THE RV LEAD EXHIBITED INCREASED THRESHOLD. WHEN THE PATIENT SAT DOWN, THE MEASUREMENTS CHANGED SIGNIFICANTLY, SHOWING THE LEAD'S INSTABILITY. DUE TO THE PATIENT'S STATURE, THE PHYSICIAN ELECTED TO USE A FIXATION LEAD. A PUNCTURE AT A NEW SITE WAS ATTEMPTED YET KEPT FAILING DUE TO THE THICK SUBCUTANEOUS TISSUE AND THE TORTUOUSLY ALIGNED VEINS OF THE PATIENT. THE EXISTING RV LEAD WAS THEREFORE CUT AND A SHEATH INSERTED OVER IT TO INSERT THE NEW RV LEAD. THE RV LEAD WAS POSITIONED SUCCESSFULLY BY FIXING THE HELIX ONCE ENOUGH SLACK HAD BEEN CREATED. ACCORDING TO THE X-RAY PHOTO THE NEXT DAY, THE NEW RV LEAD SEEMED TO HAVE SLIGHTLY DISLODGED, HOWEVER NO PACING FAILURE HAD OCCURRED. THE PHYSICIAN ELECTED TO CLOSELY OBSERVE THE PATIENT GOING FORWARD. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639270 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 00063 YR A3DR01 IPG