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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 4675
Patient Problem Undesired Nerve Stimulation (1980)
Event Type  Injury  
Event Description
The patient experienced phrenic nerve stimulation.Lv safety margin reprogrammed from +auto to +0.5v.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 Key17904928
MDR Text Key325367374
Report NumberMW5146731
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 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4675
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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