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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 G125
Patient Problem Vascular Dissection (3160)
Event Type  Injury  
Event Description
During lv (left ventricular) lead attempt, patient¿s coronary vein was dissected during cannulation.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 Key18894821
MDR Text Key337659450
Report NumberMW5152705
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 Received03/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberG125
Was Device Available for Evaluation? No
Patient Sequence Number1
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