BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992435 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09881
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO EMI (ELECTROMAGNETIC INTERFERENCE)/NOISE. THERE WERE SOME ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EPISODE ELECTROGRAMS WITH APPARENT NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN RECENTLY ON THE SAME SIDE AS THE DEVICE. THE FALL WAS POSSIBLY DUE TO A DROP IN HEART RATE. THE PATIENT WAS SYMPTOMATIC AND WAS HOSPITALIZED WHEN THEIR HEART RATE DROPPED TO AS LOW AS 30 BEATS PER MINUTE. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE NOT CAPTURING AT MAXIMUM OUTPUT, AND THE RA LEAD ALSO EXHIBITED NOISE/ARTIFACT ON THE ELECTROGRAM. THE PHYSICIAN SUSPECTED THE LEADS HAD SUBCLAVIAN CRUSH, INSULATION BREACH, OR FRACTURE. NO CHANGES WERE NOTED UPON DOING ISOMETRIC EXERCISES. THE DEVICE WAS REPROGRAMMED AND THE LEADS WERE LATER 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
    467718 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R (B)(4) IPG, 5092-52 LEAD