BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX

    MDR report key: 3151934 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05585
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. BLOOD WAS NOTED ON THE DISTAL ELECTRODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY TESTED THE HELIX OF THE IMPLANTABLE PACING LEAD PRIOR TO IMPLANT. AFTER INSERTION, FLUOROSCOPY REVEALED THAT THE HELIX HAD EXTENDED DURING INSERTION. THE PHYSICIAN ATTEMPTED TO RETRACT THE HELIX BUT WAS UNABLE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252347 CAPSURE FIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R