BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 3992880 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01942
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2013
    Report Date
    May 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. CONCOMITANT: 5054-52 LEAD IMPLANTED: 2012-(B)(6).

    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 DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE HAD FOREIGN MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING OBSERVED IN THE RIGHT ATRIAL LEAD. IT WAS FURTHER REPORTED THAT DURING POCKET MANIPULATION TESTING OVERSENSING WAS OBSERVED IN BOTH THE ATRIAL AND VENTRICULAR LEADS. BOTH LEADS WERE CONFIRMED BY X-RAY IMAGES TO BE CONNECTED SECURELY TO THE DEVICE AND WILL CONTINUED TO BE MONITORED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION INDICATED THAT THE NOISE/OVERSENSING IN BOTH LEADS CONTINUED WHILE APPLYING STRESS TO THE DEVICE IN THE POCKET AND THE DEVICE WAS NOT ABLE TO MEASURE LEAD IMPEDANCE MANUALLY. AFTER EXTENSIVE TESTING AND MONITORING THE PHYSICIAN COULD NOT CONFIRM LEAD ISSUE AND SUSPECTED A DEVICE FAILURE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468689 ADVISA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A5DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 5554-45 LEAD