BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3863150 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06563
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT MEDICAL PRODUCTS: 5086MRI52 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS REVEALED THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION AND THE VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE BREACHED INSULATION DID CONTRIBUTE TO THE ELECTRICAL COMPLAINT OF UNDERSENSING AND IT APPEARS TO HAVE BEEN CAUSED AT THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXTRACARDIAC MUSCLE STIMULATION AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WITH NO MEASURABLE P WAVES. THE LEAD WAS EXPLANTED 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
    339539 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 00043 YR Hospitalization| R RVDR01 IPG