BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2291046 · Received October 13, 2011

    Report

    Report Number
    2649622-2011-15370
    Event Type
    Injury
    Date Received
    October 13, 2011
    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

    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. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(4)-2011 17:26:17. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4)-2011 17:26:17. TEN - VENTRICULAR NST <=210 MS BETWEEN (B)(4)-2011 14:14:57 AND (B)(4)-2011 22:29:08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE ATRIAL AND VENTRICULAR LEADS EXHIBITED OVERSENSING AND NOISE WITH A MIRROR IMAGE ELECTROGRAM (EGM). IT WAS THOUGHT THAT THE CAUSE OF THE NOISE WAS THE LEADS MOVING IN OPPOSITE DIRECTION RELATIVE TO EACH OTHER. THE LEADS WERE REPROGRAMMED AND REMAIN IN USE. 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 59 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB