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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Dizziness (2194)

Event Date 07/01/2016

Event Type  Injury  

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.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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 Key: 6503540
• MDR Text Key: 73182009
• Report Number: 1644487-2017-03641
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2017
• Device Model Number: 106
• Device Lot Number: 203479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/19/2017; 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR