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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/11/2015
Event Type  Injury  
Event Description

It was reported the patient's vns generator had reached normal ifi = yes (intensified follow-up indicator) and she was referred for normal replacement surgery. However, it was also noted that the device was mobile and causing the patient discomfort. The patient reported she sleeps with a blanket on her chest to keep the generator in place. The migration will be resolved at the time of the replacement surgery. The device diagnostics have been checked and it was noted the device is working as intended as all diagnostic results were within normal limits. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Device evaluated by mfr, (b)(4). Device evaluation is not necessary because the reported migration has been determined as not related to vns therapy.

 
Event Description

It was reported the patient underwent vns generator replacement surgery due to normal battery depletion and to reposition the generator due to discomfort that was caused when the generator had migrated. The generator was received by the manufacturer. While analysis is expected, it has not been completed to date.

 
Event Description

Product analysis (pa) for the returned generator was completed. It should be noted that the reported migration and pain are outside the scope of the pa laboratory. However, proper functionality of the vns generator in its ability to provide appropriate programmed output currents can be verified. This was successfully verified in the pa lab. There were no performance or any other types of adverse conditions found with the vns generator. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6474087
Report Number1644487-2017-03587
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number103
Device LOT Number201889
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/30/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/27/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/07/2017 Patient Sequence Number: 1
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