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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 Date 05/12/2010
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported through clinic notes that the patient reported that since he was implanted with the vns, the patient had had a worsening in seizures, both in frequency and intensity. He also had significant discomfort in the chest, adjacent to the pulse generator. The physician referred the patient for explant of generator and lead so that the patient could have an mri. The patient's generator battery had reportedly been completed depleted for several years. The programming history database found that the patient's generator battery was disabled due to end of service in (b)(6) 2017. The lead and generator were explanted but the suspect product has not been received to date. No further relevant information has been received to date.

 
Event Description

It was reported that the explanted lead and generator were discarded. No further relevant information has been received 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 Key6924716
Report Number1644487-2017-04558
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number103
Device LOT Number2518
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2009
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: 10/06/2017 Patient Sequence Number: 1
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