BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1925077 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13700
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND WITH THE BATTERY VOLTAGE. ON (B)(4)-2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.83 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.96 V. THIS DIFFERENCE IS WITHIN EXPECTATIONS (<150 MV). THERE WAS OVERSENSING. ELEVEN NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES OF LESS THAN 220 MS WERE RECORDED BETWEEN (B)(4)-2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DISPARITY BETWEEN THE DAILY BATTERY VOLTAGE MEASUREMENTS AND THE ONE DISPLAYED AT INTERROGATION ON THE PACEMAKER. IT WAS ALSO REPORTED THAT THERE WERE SEVERAL NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND OVERSENSING ON THE VENTRICULAR LEAD. BOTH THE PACEMAKER AND LEAD ARE STILL 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 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 5076 IMPLANTABLE PACING LEAD