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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 100 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 100 GENERATOR Back to Search Results
Model Number 100
Event Date 07/09/1999
Event Type  Malfunction  
Event Description

The patient reported on the vns therapy (b)(6) that she had vns removed. She reported that vns did not work for her because she could not tolerate the titrated settings that had to be reached to help her. Overall, she did indicate that she sees vns helping so many people and supports it, but notes for her, it did not work due to tolerability reasons. There was previously a report from the patient that the patient experienced severe painful stimulation during vns stimulation and experienced seizures for about two weeks after programming current adjustments. Prior to adjustment, the patient had been seizure free for 3 months. The patient inquired on whether the stimulator could have been implanted wrong or could be on another nerve. It was previously noted that the patient had been explanted in (b)(6) 2000. There is no record of the generator being received by the manufacturer for analysis. Review of the manufacturer's database did not reveal any in house programming history for this patient's device. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 100
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 Key5528368
Report Number1644487-2016-00650
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Report Date 03/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2003
Device MODEL Number100
Device LOT Number4678
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2001
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: 03/27/2016 Patient Sequence Number: 1
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