BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1925846 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14072
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    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
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SENSING ANOMALIES WERE FOUND. FIVE NON-SUSTAINED TACHY EVENTS LOGGED BETWEEN (B)(4) 2010, BUT NONE WERE LESS THAN 220 MS. LOWEST WAS 350 MS. AVERAGE OF ZERO VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) PER DAY BEFORE (B)(4)-2008 ROSE TO AN AVERAGE OF 10.2 V-SICS PER DAY BETWEEN (B)(4)-2008 AND (B)(4)-2010. AN ELEVATED V-SIC COUNT CAN BE INDICATIVE OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ATRIAL AND VENTRICULAR ELECTROGRAM (EGM). NO OUT OF RANGE IMPEDANCES OR THRESHOLDS WERE NOTED. IT WAS FURTHER REPORTED THAT A CHEST X-RAY SHOWED AN ACUTE PINCH IN BOTH LEADS NEAR THE HEADER BLOCK AND INTERMITTENT OVERSENSING WAS OBSERVED WHEN THE PATIENT'S ARM WAS LIFTED. THE LEADS 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR