FDA Adverse Event Death Summary report: N

VITALITY HE

MDR report key: 1063069 · Received June 10, 2008

Report

Report Number
1063069
Event Type
Death
Date Received
June 10, 2008
Date of Event
January 28, 2008
Report Date
June 7, 2008
Manufacturer
BOSTON SCIENTIFIC
Product Code
LWS
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

PATIENT WITH A HISTORY OF NONISCHEMIC CARDIOMYOPATHY WITH AN EF OF 20%, DYSLIPIDEMIA, HTN, CRI, A HISTORY OF CHRONIC DVT/PE ON COUMADIN AS AN OUTPATIENT WHO INITIALLY PRESENTED TO AN OSH AFTER HIS ICD WAS BEEPING AND WAS FOUND TO HAVE A LOW BATTERY. AT THE OUT SIDE OF HOSPITAL (OSH), THE PATIENT HAD HIS ICD GENERATOR CHANGED SIX DAYS AFTER THE BEEPING. IN THE RECOVERY AREA AFTER THE ICD CHANGE, THE PATIENT DEVELOPED INCREASING SHORTNESS OF BREATH, BECAME HYPERTENSIVE TO THE 170S/140S, AND BECAME TACHYCARDIC. CXR WAS C/W FLASH PULMONARY EDEMA. THE PATIENT WAS INTUBATED AND TAKEN TO THE CCU. DURING HIS STAY IN THE CCU, THE PATIENT CODED AND HE EXPERIENCED EPISODES OF VT REQUIRING BOTH EXTERNAL AND INTERNAL SHOCKING BY HIS DEVICE AS WELL AS CPR. HE ALSO EXPERIENCED AN EPISODE OF PEA. PER THE NOTES, HIS ICD DELIVERED ROUGHLY 24 SHOCKS DURING THIS CODE. AMIODARONE AND LIDOCAINE WERE BOTH STARTED. THE PATIENT DEVELOPED ACUTE RENAL FAILURE AND HE WAS PLACED ON CRRT. PATIENT DIED AFTER WITHDRAWAL OF LIFE SUPPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VITALITY HE ICD LWS BOSTON SCIENTIFIC T180 *
2 * LEAD, ICD LWS BOSTON SCIENTIFIC 4087 *
3 * LEAD, ICD LWS BOSTON SCIENTIFIC 0158 *

Patients

Seq Age Sex Outcome Treatment
1 29 YR Death CARDIAC DRUGS| CARDIAC DRUGS