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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2017
Event Type  Injury  
Event Description

The patient was experiencing a painful shocking feeling in his neck at the lead site that occurred with every stimulation. The device was disabled using the magnet. The next day, the painful stimulation returned and the patient was also experiencing an increase in seizures and his neck appeared to be pulsing at the site of the lead. The patient¿s school nurse attempted to disable the generator with the vns magnet however this did not inhibit stimulation. Due to the pain, the patient was taken to the surgeon to have the device programmed off. The surgeon performed diagnostic testing and x-rays and it was reported that everything seemed ok. Further follow-up found that a week prior to the pain and muscle spasm events, the generator¿s settings were increased as a part of normal titration. The physician later reported that the seizure rate was the same as pre-vns baseline and that the settings were still being titrated so the patient had not yet reached efficacious settings. The physician also confirmed that the magnet placement was appropriate to disable the device. The patient underwent surgery where the generator was replaced. The explanted device has not been received by the manufacturer to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

The initial report inadvertently did not include information that the device had been received by the manufacturer. ¿no, 02¿ the initial report inadvertently stated the device had not been received to the manufacturer. However the device had been received and was pending analysis. (b)(4). The initial report inadvertently did not include information that the device had been received to the manufacturer and was pending analysis. (b)(4).

 
Event Description

The device was received by the manufacturer and the device underwent product analysis has been completed. The internal data of the generator was reviewed and it indicated that the generator had 172 successful magnet swipes since the manufacture date, including 15 magnet mode activations that occurred around the time that it was reported that the magnet did not inhibit vns stimulation. During functional analysis magnet activations were performed normally. Product analysis found that the device operated within specifications.

 
Manufacturer Narrative

Date received by manufacturer, corrected data: follow up report # 1 had the wrong date for the information received by the manufacturer. The correct date should have been 03/16/2017.

 
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Brand NamePULSE GEN MODEL 106
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 Key6381018
Report Number1644487-2017-03333
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 05/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/07/2018
Device MODEL Number106
Device LOT Number203851
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2016
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: 03/06/2017 Patient Sequence Number: 1
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