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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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BOSTON SCIENTIFIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number 4543
Patient Problem Tachycardia (2095)
Event Type  Injury  
Event Description
Reason for check: pt in ed, unresponsive initially.History of pt with having trouble with device 3 days ago.Pt.Discharged and then today pt was unresponsive in bedroom.A few times on monitor pt had runs of vt and almost had to do chest compressions.Pt's getting transferred to specialist that installed device tonight.Unable to measure lv thresholds in last 7 days.Lv output programmed monitor only.Unable to confirm lv capture on current egm.High rv threshold on (b)(6) 2023; 11 nsvt; most recent on (b)(6) 2023.Some episodes possibly more sustained with rates above/below detection zones at times and did not met criteria for therapies.Intermittent atrial under sensed beats.Intermittent ventricular over/under sensed beats.V-sensing episodes, most recent on (b)(6) 2023.Vt detection zone is on for rates 130bpm for 16 consecutive beats.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Ref reports: mw5152658, mw5152659.
 
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Brand Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key18886704
MDR Text Key337647840
Report NumberMW5152657
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4543
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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