BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1648073 · Received April 1, 2010

    Report

    Report Number
    2015691-2010-13006
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    January 23, 2010
    Report Date
    March 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) = ATRIAL VENTRICULAR DISRUPTION, MASSIVE BLEEDING, SEVERE HYPOTENSION, LOW CARDIAC OUTPUT, IRREVERSIBLE V-FIB, AND PROGRESSIVE ACIDOSIS. ON 04/16/2010, THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, THE OPERATIVE REPORT OF (B) (6) 2010, AND THE DISCHARGE SUMMARY WAS PROVIDED. THROUGH WHICH IT WAS LEARNED THAT THE PATIENT EXPIRED DUE TO POST-OPERATIVE COMPLICATIONS. (B) (4)

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE OPERATIVE REPORT AND ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    HUSBAND PLACES CALL TO REP TO COMPLAIN ABOUT BATTERIES AND LABELING OF BATTERIES/UNIT. HUSBAND STATES THAT AFTER REPLACING ELECTRODE/BATTERY IN UNIT THAT WIFE STILL FELT NO STIMULATION AND UNIT WOULD NOT TURN ON. HUSBAND TOLD REP THAT HE PUT ELECTRODES ON HIS WIFE, CONNECTED LEADS TO ELECTRODES, LEADS TO UNIT AND CONTINUED TO TURN UP THE DIALS AS HIGH AS THEY WOULD GO TO SEE IF WIFE WOULD FEEL STIMULATION. WITH UNIT TURNED AS HIGH AS IT WOULD GO AND UNIT STILL ATTACHED TO WIFE - OPENS UNIT REMOVES BATTERY, NOTICES HE DID NOT REMOVE PLASTIC TAMPER PROOF SEAL. REMOVES PLASTIC COVERING FROM BATTERY AND PLACES BATTERY BACK INTO UNIT. THE PT IMMEDIATELY RECEIVES AN EXTREME PAINFUL JOLT OF ELECTROSTIMULATION AS THE UNIT WAS NOT TURNED OFF/REMOVED FROM HER BODY BEFORE PUTTING BATTERY BACK INTO UNIT. HUSBAND UPSET THAT THERE WERE NO WARNINGS ON UNIT OR BATTERY TO MAKE SURE UNIT IS TURNED OFF BEFORE PUTTING IN BATTERY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2010-01193 AND 3005099803-2010-01196. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT THREE C.R.E. WIREGUIDED BALLOON DILATATION CATHETER DEVICES WERE USED DURING A DUODENAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CRE BALLOON WAS NOT PROPERLY DEFLATED AND AS A RESULT, THE DEVICE GOT STUCK IN THE SCOPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH C.R.E. WIREGUIDED BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-09C0422

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death