BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 1833004 · Received September 14, 2010

    Report

    Report Number
    2647346-2010-00521
    Event Type
    Death
    Date Received
    September 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD VT (VENTRICULAR TACHYCARDIA) AND "THEY APPLIED AN EXTERNAL PACEMAKER WITH THE PADS IN THE RIGHT PECTORAL AND LEFT AUXILLARY POSITION. WHEN THE CARDIOLOGIST STOPPED THE EXTERNAL PACING THE PACEMAKER WAS INHIBITED." IT WAS FURTHER REPORTED THAT "THERE WERE NO PACING SPIKES FOR HALF AN HOUR SO TOTAL INHIBITION OF THE PACEMAKER." THE PHYSICIAN QUESTIONED IF THERE WAS DAMAGE TO THE DEVICE FROM THE HIGH OUTPUT EXTERNAL PACING. THE PATIENT DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD VT (VENTRICULAR TACHYCARDIA) AND "THEY APPLIED AN EXTERNAL PACEMAKER WITH THE PADS IN THE RIGHT PECTORAL AND LEFT AUXILLARY POSITION. WHEN THE CARDIOLOGIST STOPPED THE EXTERNAL PACING THE PACEMAKER WAS INHIBITED." IT WAS FURTHER REPORTED THAT "THERE WERE NO PACING SPIKES FOR HALF AN HOUR SO TOTAL INHIBITION OF THE PACEMAKER." THE PHYSICIAN QUESTIONED IF THERE WAS DAMAGE TO THE DEVICE FROM THE HIGH OUTPUT EXTERNAL PACING. THE PATIENT DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE PHYSICIAN REPORTED "THE PATIENT WAS RESUSCITATED DUE TO A CARDIAC CONDITION AND NOT DUE TO THE PACEMAKER." AFTER RESUSCITATION, HE SAID THEY TOOK THE EXTERNAL PACING OFF AND THERE WERE NO PACING SPIKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR ASKU NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death