BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153326 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05941
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE WITH 2098 LOW IMPEDANCE PACES RECORDED POST LEAD WARNING ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A POLARITY SWITCH TO UNIPOLAR AND IN A PERIOD OF ONE WEEK THERE WERE 100,000 LOW IMPEDANCE COUNTS. IT WAS NOTED THAT SENSING AND THRESHOLDS WERE GOOD AND HAD NO CHANGE AND THAT ISOMETRICS AND POSITIONS WERE TRIED TO REPLICATE THE LOW IMPEDANCE BUT WITHOUT SUCCESS. IT WAS ALSO REPORTED THAT THE BIPOLAR IMPEDANCE WAS 614 OHMS AND THE UNIPOLAR WAS 616 OHMS. THE RV LEAD WILL CONTINUE TO BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE RV LEAD CONTINUED TO HAVE INTERMITTENTLY LOW IMPEDANCE LEAD WARNINGS AND POLARITY SWITCHES. IT WAS ALSO REPORTED THAT THE PATIENT WAS FEELING SOME PECTORAL TWITCHING WITH UNIPOLAR PACING. DUE TO THE PATIENT ANATOMY AND HISTORY IT WAS ELECTED TO CONTINUE TO MONITOR THE RV LEAD CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255979 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR SEDR01 IMPLANTABLE PULSE GENERATOR