BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790955 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14478
    Event Type
    Malfunction
    Date Received
    October 15, 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
    OH, 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. 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. SENSING - INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=11 COUNTS AVG/DAY, IN 9.61 DAYS, BETWEEN (B)(4) 2012 21:13:34 AND (B)(4) 2012 1:45:03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN APPARENT INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR (RV) LEAD AND THAT THE PATIENT WAS ASYMPTOMATIC. IT WAS ALSO REPORTED THAT THERE WERE NOTED NON-SUSTAINED TACHYCARDIAS (NSTS) AND VENTRICULAR FIBRILLATION (VF) EPISODES THAT APPEAR TO BE T-WAVE OVERSENSING (TWOS) AND NOISE ON THE ELECTROGRAM (EGM.) IT WAS FURTHER REPORTED THAT R-WAVE DECREASED AND THRESHOLDS HAVE RISEN. IT WAS LATER REPORTED THAT THE RV AND RIGHT ATRIUM (RA) LEADS DISLODGED. THE RV AND RA LEADS WERE MODIFIED AND REMAIN IN USE. IT WAS NOTED THAT THE PATIENT IS PART OF THE (B)(4) STUDY. NO FURTHER 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB