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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Report received through clinic notes that a patient presented with an increase in seizures. The patient's seizures increased from 10 days of seizures per month to 15 seizures per month over a span of about six months. The patient's generator was interrogated in the clinic and the settings were provided. It was stated that the generator was at end of service but the physician also indicated that battery life still remained. A review of the programming history only provided data from the day of implant, but showed diagnostics were normal at the time. The patient's generator was replaced and the generator was returned to the manufacturer. Product analysis has not been completed to date. No further relevant information has been received to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Product analysis was completed on the generator. Besides normal markings and discoloration seen with the implant and explant procedure, no visual anomalies were seen. The generator was interrogated and system diagnostics were run. All results were normal. The generator output was monitored in a simulated body environment and did not show any variation in expected output current. The generator also passed all electrical tests and performed according to all specifications. The battery voltage was measured and indicated the generator had been able to provide stimulation prior to explant. The data from the generator was also reviewed and did not show any anomalies. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 104
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 Key7047049
Report Number1644487-2017-04839
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number104
Device LOT Number203083
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/12/2014
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: 11/20/2017 Patient Sequence Number: 1
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