BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812350 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15688
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED REGARDING THE LEAD WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED 14 NONSUSTAINED VENTRICULAR TACHYCARDIA EPISODES HAD OCCURRED SINCE (B)(6) 2012, EIGHT OF WHICH AVERAGED LESS THAN 210MS V-V INTERVALS. ADDITIONALLY, WEEKLY IMPEDANCE READINGS WERE STABLE UNTIL THE WEEK ENDING (B)(6) 2012. THE MAXIMUM IMPEDANCE MEASURED WAS OUT OF RANGE. DAILY IMPEDANCE READINGS WERE INTERMITTENT, INDICATING A FAILURE TO MEASURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND LANDED ON THEIR LEFT SHOULDER; THE FALL WAS NOT BELIEVED TO BE RELATED TO SYSTEM PERFORMANCE. IT WAS ALSO REPORTED THAT AFTER THE PATIENT'S FALL, THE RIGHT VENTRICULAR [RV] LEAD HAD LOSS OF CAPTURE AND INTERMITTENT HIGH IMPEDANCE MEASUREMENTS. 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 MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R 5592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR