BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2864904 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17596
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCT: 5592 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 REVEALED THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE HIGH. THE SAVE TO DISK FILE DATA SHOWS VENTRICULAR LEAD ALERT TIME OF (B)(6) 2012. THE VENTRICULAR IMPEDANCE AT IMPLANT EQUALED 838 OHMS AND VENTRICULAR LIFETIME IMPEDANCE MAX/MIN EQUAL TO OPEN/371 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE. INTERROGATION SHOWED STABLE RV IMPEDANCE TREND AROUND 500 OHMS PRIOR TO A SUDDEN INCREASE TO GREATER THAN 9,999 OHMS (UNIPOLAR AND BIPOLAR PACING IMPEDANCES) THERE WAS NO APPARENT PACING CAPTURE AT MAXIMUM DEVICE OUTPUT WITH BOTH UNIPOLAR AND BIPOLAR. THE R-WAVES WERE SENSED BETWEEN 2.0-2.8 MILLIVOLTS IN A BIPOLAR SENSE POLARITY. THERE WAS A HIGH NUMBER OF VENTRICULAR HIGH RATE EPISODES COLLECTED OVER A FIVE WEEK PERIOD AND EACH ELECTROGRAM DEMONSTRATED APPARENT VENTRICULAR OVERSENSING AT A NON-PHYSIOLOGIC RATE. THE RV LEAD WAS CAPPED 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
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R E2DR01AA IMPLANTABLE PULSE GENERATOR