BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES SR

    MDR report key: 2791129 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14202
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    February 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE SAVE TO DISK FILE (B)(4), SHOWED A PARTIAL RESET COUNTER OF ONE. FIRMWARE (FW) REASON HEXADECIMAL (HEX) WAS 0000, THE WRITE DATA (WD) REASON HEX OF 28, RESET WD REASON AS THE CLOCK STOP STATUS, VDIFFLS STATUS, ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET HAD OCCURRED ON THE DEVICE. NO ACTION WAS TAKEN BECAUSE ALL PROGRAMMED PARAMETERS WERE STILL THE SAME. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC PUERTO RICO, INC. C20A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other