BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA VDD

    MDR report key: 2697563 · Received August 14, 2012

    Report

    Report Number
    6000094-2012-01737
    Event Type
    Injury
    Date Received
    August 14, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S097
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) - THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS HIGH RESISTANCE/IMPEDANCE AND SAVE TO DISK FILE (B)(4) DATA SHOWS VENTRICULAR LEAD ALERT TIME EQUAL TO (B)(6) 2012, 3:28 PM. VENTRICULAR IMPEDANCE AT IMPLANT EQUAL TO 838 OHMS. VENTRICULAR LIFETIME IMPEDANCE MAX/MIN EQUAL TO 1212/357 OHMS.

    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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SYNCOPE. UPON DEVICE INTERROGATION IT WAS FOUND THERE WAS A LEAD POLARITY SWITCH FROM BIPOLAR TO UNIPOLAR AND THE DEVICE WAS INTERMITTENTLY NOT PACING OR CAPTURING. DURING A REVISION, WHEN THE DEVICE WAS CONNECTED TO A NEW LEAD AND IN PACING MODE VVI THERE WERE PAUSES NOTED AND THERE WAS CONCERN THE DEVICE MAY BE MALFUNCTIONING. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIA VDD IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. REVDD01

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| O| R