BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952949 · Received February 9, 2013

    Report

    Report Number
    6000095-2013-00004
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    February 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ANALYSIS FOUND NO ANOMALIES AND NO RESETS WERE NOTED.

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    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 A FOLLOW UP VISIT, THE SENSING TEST AND THRESHOLD TEST COULDN'T BE PERFORMED IN THE USUAL WAY. WHEN PERFORMING THE SENSING TEST, P-WAVES AND R-WAVES WERE DETECTED BY THE DEVICE INDICATED BY ATRIAL SENSE AND VENTRICULAR SENSE EVENT MARKERS, BUT NO VALUES OF AMPLITUDES WERE DISPLAYED. THE TEST WAS PERFORMED MANUALLY BY CHANGING THE SENSITIVITY VALUES AND SHOWED GOOD SENSING VALUES. WHEN PERFORMING THE THRESHOLD TESTS THE AUTOMATIC STEPDOWN PROCEDURE DIDN'T WORK. THE MEASUREMENT WAS PERFORMED MANUALLY AND SHOWED LOW THRESHOLDS. IT WAS DETERMINED THAT THE DEVICE WAS IN NEED OF A MANUAL GUIDED RESET. 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
    57416 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE NVZ IPG MFG SWITZERLAND C60A2U

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention