BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2201693 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11171
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE AND LEAD WERE NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 2 - PORS (POWER ON RESET) ON (B)(6) 2011. 1- PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 10:02:20. DAILY PACE IMPEDANCE TREND DATA SHOW THE IMPEDANCE FOR VENTRICULAR PACE BI IMPEDANCE= 4047 OHMS AND ATRIAL PACE BI IMPEDANCE=4047 OHMS BETWEEN (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ATRIAL PACING IMPEDANCE WAS GREATER THAN 3000 OHMS WITH A LEAD WARNING ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY FOR BREAST CANCER AND THERE WAS AN ELECTRICAL RESET. THE RIGHT ATRIAL (RA) LEAD THE RIGHT VENTRICULAR (RV) LEAD AND BOTH LEFT VENTRICULAR (LV) LEADS SHOWED HIGH RESISTANCE/IMPEDANCE. IT WAS ALSO REPORTED THAT THE POWER-ON-RESET WAS CAUSED BY A POWER SUPPLY ISSUE WHICH MAY BE RELATED THE PATIENT'S SURGERY. THE FOLLOW-UP INFORMATION OBTAINED COULD NOT CONFIRM IF THERE WAS ANY INTERVENTION DONE. THE SYSTEM REMAINS IN USE. 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 MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other