BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI

    MDR report key: 3153084 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05807
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. BLOOD WAS NOTED ON THE DISTAL END. THE ANALYST COMMENTED THAT THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD WAS REPOSITIONED AND THEN THE HELIX WOULD NOT EXTEND WHEN RE-FIXING TO ATRI UM. AFTER 10-12 SLOW TURNS, THE PHYSICIAN COMMENTED THAT HE WAS NOT GETTING THE FEEDBACK THAT HE TYPICALLY GOT WITH THIS LEAD. THE PHYSICIAN SAID THAT IT FELT LIKE SOMETHING PROXIMAL SUCH AS THE ROTATION MECHANISM ITSELF ON THE LEAD FELT LOOSE AND WAS 'GRINDING' WHEN ROTATED. UPON REMOVAL OF THE LEAD IN QUESTION, THE HELIX FINALLY EXTENDED, BUT THE PHYSICIAN REQUESTED A NEW LEAD. ANOTHER LEAD WAS IMPLANTED WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256166 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR