BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964939 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01546
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD; 4194 IMPLANTABLE PACING LEAD. (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 LEADS WERE NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. LEAD FAILURE PREDICTOR ALERTS WERE RECORDED ON (B)(6) 2012. THERE WERE FIVE EPISODES OF NON-SUSTAINED TACHYCARDIA AND FIVE EPISODES OF LEAD FAILURE PREDICTOR OF LESS THAN 220 MS WERE OBSERVED ON (B)(6) 2012. THERE WERE 290 V-SHORT INTERVAL COUNTS (SIC) THAT OCCURRED BEGINNING (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD TRIPPED THE LEAD INTEGRITY ALERT WITH OVERSENSING AND NOISE. IT WAS SUSPECTED THAT THE RV LEAD HAD A POSSIBLE FRACTURE. THE RV LEAD WAS CAPPED AND A CHRONIC RV LEAD WAS REACTIVATED. THERIGHT ATRIAL (RA) LEAD SHOWED A GRADUAL INCREASE TO HIGH IMPEDANCE AND HIGH THRESHOLDS. THE RA LEAD WAS REPLACED. IT WAS ALSO FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHEN ATTEMPTING TO INTERROGATE THE DEVICE HAD A POP UP WINDOW THAT INDICATED "DETECTION NOT ACTIVE" AND THE DEVICE WAS INACTIVE DURING THE ENTIRE FOLLOW-UP APPOINTMENT. THE ICD 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
    68702 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R D394TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC