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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS DEMIPULSE CYBERONICS VNS PULSE GENERATOR

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CYBERONICS DEMIPULSE CYBERONICS VNS PULSE GENERATOR Back to Search Results
Event Date 01/05/2011
Event Type  No Answer Provided  
Event Description

Explantation of cyberonics vns demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

 
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Brand NameDEMIPULSE
Type of DeviceCYBERONICS VNS PULSE GENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd.
houston TX 77058
MDR Report Key2061420
Report Number2061420
Device Sequence Number1
Product CodeLYJ
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/08/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2011
Event Location Hospital

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