BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2605981 · Received June 8, 2012

    Report

    Report Number
    6000094-2012-01045
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    February 23, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE DEVICE WAS DAMAGED. ALSO, THE SOLDER JOINT HAD ELECTRICAL DISCONTINUITY AND WAS OPEN. THE NO OUTPUT CONDITION WAS THE RESULT OF A FRACTURED SOLDER JOINT ON A BOND PAD ARRAY. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED RESISTANCE/IMPEDANCE INCREASE WITH ATRIAL AND VENTRICULAR IMPEDANCE INCREASED TO UPPER LIMIT ON APPROXIMATELY (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN APPROXIMATELY A MONTH POST IMPLANT OF THE DEVICE THAT THE UNIPOLAR IMPEDANCE IN BOTH CHAMBERS JUMPED TO INFINITY AT THE SAME TIME. IT WAS REPORTED THE DEVICE ALSO STOPPED UNIPOLAR CAPTURE IN BOTH CHAMBERS AT THIS TIME. IT WAS NOTED THAT THE BIPOLAR PARAMETERS REMAINED NORMAL AND THAT AT IMPLANT BOTH THE UNIPOLAR AND BIPOLAR CONFIGURATIONS FUNCTIONED NORMALLY. 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
    1 ADVISA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5086MRI X2 IMPLANTABLE PACING LEADS