BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2791019 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02278
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    August 24, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND ASYSTOLE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS COMPLETE ATRIOVENTRICULAR BLOCK WAS SEEN ON THE PATIENT'S ELECTROGRAM. THE PATIENT'S DEVICE WAS EVALUATED AND IT WAS FOUND TO BE PACING NORMALLY AS THE "HEART RATE STOPPED SHOWING ASYSTOLE TO THE PACEMAKER COMMAND." THE PATIENT WAS BROUGHT TO THE OPERATING ROOM BUT PRIOR TO THE INCISION, "SHOWED ASYSTOLE." WHEN THE PATIENT'S DEVICE WAS REMOVED, IT WAS NOTED THAT THERE WAS A LOOSE SETSCREW; WHEN THE DEVICE WAS RECONNECTED TO THE RIGHT VENTRICULAR [RV] LEAD, LOSS OF CAPTURE WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND ASYSTOLE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS COMPLETE ATRIOVENTRICULAR BLOCK WAS SEEN ON THE PATIENT'S ELECTROGRAM. THE PATIENT'S DEVICE WAS EVALUATED AND IT WAS FOUND TO BE PACING NORMALLY AS THE "HEART RATE STOPPED SHOWING ASYSTOLE TO THE PACEMAKER COMMAND." THE PATIENT WAS BROUGHT TO THE OPERATING ROOM BUT PRIOR TO THE INCISION, "SHOWED ASYSTOLE." WHEN THE PATIENT'S DEVICE WAS REMOVED, IT WAS NOTED THAT THERE WAS A LOOSE SETSCREW; WHEN THE DEVICE WAS RECONNECTED TO THE RIGHT VENTRICULAR [RV] LEAD, LOSS OF CAPTURE WAS OBSERVED. THE DEVICE WAS 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 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R