BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200565 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11013
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    March 7, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. ANALYSIS OF THE TWO LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE DEFIBRILLATOR DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. DAILY AND WEEKLY IMPEDANCE TRENDS ARE STEADY AND IN RANGE FOR THE RV PACE CIRCUIT. RV LEAD INTEGRITY WARNING ON (B)(6) 2010. 15 SHORT V-V CYCLE EPISODES (<220MS PERIOD) NOTED ON (B)(6) AND (B)(6) 2010. BETWEEN (B)(6) AND (B)(6) 2010 THERE WERE 265 V-SICS (SHORT INTERVAL COUNT) (AVE 34.8 V-SIC/DAY). IN THE DAY PRIOR TO THIS SESSION, THERE WAS ON AVE 111 V-SIC/DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED DUE TO OVERSENSING POSSIBLY CAUSED BY INTERFERENCE OR NOISE. IT WAS LATER REPORTED THAT THE DEVICE HAD REACHED THE END OF SERVICE DUE TO RIGHT VENTRICULAR (RV) LEAD FRACTURES AND MANY SHOCKS. THE RV LEAD AND DEVICE WERE EXPLANTED AND REPLACED. THE ACTIVE ATRIAL LEAD EXHIBITED NOISE AND WAS ALSO EXPLANTED AND REPLACED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Life Threatening| H| R