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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that the patient was admitted to the hospital for right sided weakness and chest pain and the patient reported that he had had chronic problems with the vns. The patient also reported focal seizures, the last of which was in (b)(6) 2018. Upon follow-up with the patient, it was reported that the patient was experiencing shortness of breath, chest pain, and pain in his throat which had reportedly been occurring on and off for the past few weeks. The on-call physician did not seem to think these symptoms were related to the vns. System diagnostics and normal mode diagnostics were ok. The patient's vns output frequency was lowered from 30 to 20 hz at the direction of the neurologist, who thought this would alleviate some of the symptoms. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key8153856
Report Number1644487-2018-02272
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/01/2013
Device MODEL Number102
Device LOT Number3006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/18/2011
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: 12/11/2018 Patient Sequence Number: 1
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