BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3863147 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06544
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE ALL PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS. FIBROTIC GROWTH WAS NOT OBSERVED ON THE HELIX.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: A2DR01 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE PHYSICIAN WAS UNABLE TO FIXATE THE RIGHT ATRIAL (RA) LEAD TO THE ATRIUM OF THE PATIENT AFTER SIX ATTEMPTS. THE PHYSICIAN REMOVED THE RA LEAD AND THERE APPEARED TO BE TISSUE ATTACHED TO THE HELIX. THE TISSUE WAS REMOVED FROM THE LEAD, HOWEVER, THE PHYSICIAN NO LONGER TRUSTED THE INTEGRITY OF THE LEAD AND REQUESTED A NEW RA LEAD TO BE IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339538 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR (B)(4) LEAD