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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported to a company representative by a vns patient¿s mother that the patient was having an increase in seizure frequency and intensity. The mother believes the battery is no longer functioning, possibly since (b)(6), and said the patient has pain in the chest and at the side of her neck and in her abdomen. The patient had 3 grandmal seizures in a 12 hour period about a week or 2 ago and as-of (b)(6) 2017 she was having a grand mal seizure every day or every other day. Generator replacement surgery occurred (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6491260
Report Number1644487-2017-03614
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number103
Device LOT Number2767
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/19/2009
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: 04/13/2017 Patient Sequence Number: 1
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