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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 Type  Injury  
Event Description

It was reported that the patient was experiencing nausea and unspecified symptoms of battery depletion, according to the patient's mother. It is unclear if the nausea is related to vns. The patient was scheduled for surgical consult as the patient's battery was at neos = yes as of a clinic visit three weeks prior.

 
Event Description

It was reported that the physician was unaware of any nausea that the patient was experiencing and as such, could not provide its cause. The physician did not suspect the nausea was related to vns. The patient also began experiencing a change in seizure type that he believes was possibly associated with the battery depletion. The patient underwent generator replacement surgery. The product was disposed of after surgery and is unavailable for analysis. No additional information has been provided 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 Key6433995
Report Number1644487-2017-03460
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2012
Device MODEL Number103
Device LOT Number2897
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/04/2011
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: 03/24/2017 Patient Sequence Number: 1
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