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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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BOSTON SCIENTIFIC CORPORATION DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number G146
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Event Description
Caller reports the patient has episodes of af.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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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 CORPORATION
MDR Report Key17862368
MDR Text Key324960186
Report NumberMW5146434
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 Unknown
Type of Report Initial
Report Date 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberG146
Was Device Available for Evaluation? No
Patient Sequence Number1
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