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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 07/01/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).

 
Event Description

It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.

 
Event Description

It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
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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 Key6503540
Report Number1644487-2017-03641
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 06/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/07/2017
Device MODEL Number106
Device LOT Number203479
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/17/2015
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: 04/19/2017 Patient Sequence Number: 1
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