BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2951932 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00074
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 9, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME FAMILY TO A DEVICE MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE DEVICE MET 80%OF EXPECTED LONGEVITY. PERFORMANCE DATA WAS ALSO COLLECT FROM THE DEVICE AND ANALYZED. ANALYSIS OF THIS DATA REVEALED THAT THERE WAS AN ALERT FOR LOW BATTERY VOLTAGE/RECOMMENDED REPLACEMENT TIME (RRT) AND THE TIME OF RRT IN THE SAVE TO DISK WAS ON (B)(6) 2012 WHERE THE DEVICE RRT WAS LESS THAN OR EQUAL TO 2.6251 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BATTERY EQUALING 2.627 TO 2.613 VOLTS BETWEEN (B)(6) 2012. THERE WAS ONE LOW BATTERY VOLTAGE ALERT ON (B)(6) 2012.

    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 THE DEVICE DID NOT MEET THE PERCEIVED LONGEVITY ESTIMATES AND IS SUSPECT OF PREMATURE BATTERY DEPLETION. 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
    57252 CONSULTA CRT-D NIK IPG MFG SWITZERLAND D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R