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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 11/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported via clinic notes received that the patient's vns generator battery was depleted. It was questioned "why new seizures. " it was unclear if this was the report of a new seizure type or an increase in seizures. Follow up with the company representative revealed that at the most recent clinic visit, the patient's vns was interrogated and found to be at an end of service, or eos, condition and pulse disabled. The last data in the manufacturer's database was from approximately a year and a half prior to the recent clinic visit. It was unknown what physician, if any, had been managing the patient's vns as the submitter of the clinic notes only managed the patient's seizures and medications, not the vns. No additional relevant information has been received to date.

 
Event Description

The patient was referred for vns replacement surgery. The patient underwent prophylactic vns generator replacement surgery. During attempts at product return, it was revealed that the explanting facility, historically, discards explanted products.

 
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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 Key7640091
Report Number1644487-2018-01080
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number103
Device LOT Number3289
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2012
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: 06/26/2018 Patient Sequence Number: 1
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