BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA SR

    MDR report key: 4161540 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02274
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A RISING IMPEDANCE AND THRESHOLD. THE LEAD WAS BEING REPLACED AND JUST BEFORE THE LEAD WAS DISCONNECTED FROM THE IMPLANTABLE PULSE GENERATOR (IPG) THE LEAD IMPEDANCE MEASURED >9999 OHMS. WHEN MEASURED THROUGH THE ANALYZER THE LEAD PARAMETERS WERE WITHIN NORMAL RANGE. IT IS UNKNOWN IF THE HIGH IMPEDANCE AND HIGH THRESHOLD IS A LEAD OR DEVICE ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED 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
    641748 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADSR03

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 5078-58 LEAD