BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4834611 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01392
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 24, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A TANTALUM CAPACITOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY ANGIOGRAPHY IT WAS NOTED THAT THE PATIENT¿S HEART RATE WAS BELOW THE PROGRAMMED LOWER RATE LIMIT OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE DEVICE WAS INTERROGATED AND SHOWED THAT IT HAD TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI) THREE MONTHS EARLIER. THE PATIENT FELT LETHARGIC WITH LOW HEART RATE. THE DEVICE WAS NOW AT END OF LIFE (EOL) WITH NO OUTPUT AND THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS LOW. IT WAS ALSO REPORTED THAT THE ESTIMATED DEVICE LONGEVITY IN (B)(6) WAS 3-5 YEARS AND IT REACHED ERI ONE MONTH LATER AND THERE WAS A LEAD WARNING. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD REMAINS 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
    378654 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R