BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160265 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07971
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. A D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2009. A 6947 IMPLANTABLE TACHY LEAD, (B)(6) 2002. (B)(4).

    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 ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE WITH TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 AND (B)(6) 2013. WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX A PACE EQUAL TO 528 TO INF(UN-FILTERED DATA) OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE AND OVERSENSING. ALSO THE RV LEAD PACE/SENSE IMPEDANCE HAD SPIKED FROM 1800 TO GREATER THAN 4000 OHMS. ALSO THE RV LEAD SUPERIOR VENA CAVA COIL IMPEDANCE HAD STARTED SPIKING FROM 60 TO GREATER THAN 200 OHMS THREE MONTHS PRIOR TO THE RV PACING IMPEDANCE SPIKES. THE RIGHT ATRIAL (RA) LEAD IMPEDANCE ALSO STARTED SPIKING TO GREATER THAN 2500 OHMS FOLLOWING A PATIENT FALL FIVE MONTHS PRIOR. THE RA LEAD ALSO HAD OVERSENSING AND UNDERSENSING WITH P-WAVES AT 0.3 TO 0.9 MILLIVOLTS. THE RV AND RA LEADS WERE BOTH CAPPED AND A NEW RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261351 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| L| R