BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRONIK

    MDR report key: 387223 · Received April 9, 2002

    Report

    Report Number
    387223
    Event Type
    Death
    Date Received
    April 9, 2002
    Date of Event
    March 26, 2002
    Report Date
    April 3, 2002
    Manufacturer
    BIOTRONIK, INC
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED FOR A SINGLE CHAMBER IMPLANTABLE CARDIAC DEFIBRILLATOR AFTER AN ELECTROPHYSIOLOGIC STUDY INDUCED MONOMORPHIC VENTRICULAR TACHYCARDIA. AT 1006, THE PHYSICIAN PLACED A COMMERCIALLY AVAILABLE PACING AND DEFIBRILLATOR LEAD. PLACEMENT WAS COMPLETED AT 1101. AT 1226, THE PT WAS TRANSFERRED TO A TRANSITIONAL CARE AREA TO RECOVER FROM THE PROCEDURE. UPON ARRIVAL TO THIS AREA, THE PT WAS FOUND TO HAVE A CHANGE IN SKIN COLOR AND TEMPERATURE, SPECIFICALLY ON PT'S LOWER EXTREMITIES, AND TACHYPNEIC WITH RESPIRATORY DISTRESS. THE PT WAS PLACED ON 100% OXYGEN, GIVEN LASIX, RESPIRATORY TREATMENT AND TRANSFERRED TO THE ICU AT 1320. IN THE ICU, THE PT CONTINUED TO HAVE MOTTLED SKIN AND PERIPHERAL PULSES (LOWER EXTREMITIES) WERE NOT DETECTABLE BY DOPPLER. DURING THE NEXT FIVE HOURS, THE PT WAS SEEN AND EVALUATED BY A SURGEON FOR BLOODY STOOLS AND THE CARDIOLOGIST. AT 1805, THE PT WAS APNEIC AND PROFOUNDLY HYPOTENSIVE WITH AN AGONAL CARDIAC RHYTHM. EMERGENCY PROCEDURES WERE INITIATED, AN EMERGENT ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION WITH TAMPONADE. AN EMERGENT PERICARDIAL WINDOW WITH RELIEF OF THE TAMPONADE WAS PERFORMED. DESPITE THIS, A VIABLE RHYTHM WAS NOT RECOVERED AND THE PT WAS PRONOUNCED AT 1828. THE FINAL DIAGNOSIS IS "PROBABLE PERFORATION OF HEART RELATED TO AICD PROCEDURE" AND "CARDIAC TAMPONADE SECONDARY TO ABOVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRONIK KAINOX DEFIBRILLATOR LEAD (DEVICE 1) LWS BIOTRONIK, INC KAINOX RV-S 124574 NI
    2 BIOTRONIK KAINOX DEFIBRILLATOR LEAD LWS BIOTRONIK, INC KAINOX RV-S 124574 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death ECOTRIN 81MG, ALTACE 5MG, LIPITOR 10MG, LANOXIN| BELOS VR 330444 (AUTOMATIC IMPLANTABLE CARDIAC| DEFIBRILLATOR), KAINOX SL 75116 124218 (SENSING| 250MCG OVER 4 HOURS, VANCOMYCIN 1 GRAM.| LEAD), ELOX 60 BP 330133 (DEFIBRILLATOR LEAD),| THE PROCEDURE: VERSED 16MG OVER 4 HOURS, FENTANYL| MEDICATIONS: (DAY OF PROCEDURE)| 0.25MG, THEOPHYLLINE 200MG, CLARITIN 10MG. DURING| ROUNTINE MEDICATIONS TAKEN IN MORNING: