MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Apnea (1720); Dysphagia/ Odynophagia (1815); Undesired Nerve Stimulation (1980); Pain (1994); Seizures (2063); Weight Changes (2607); No Code Available (3191)

Event Date 05/25/2011

Event Type  Injury  

Event Description

It was reported via clinic notes that a vns patient was experiencing an increase in seizures.The patient was referred for surgery.The physician stated the generator was interrogated and confirmed the device "is functioning well".Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement.She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2.5 minutes and her recovery can be up to a week.Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life.The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months.The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement.There is high suspicion for non-epileptic seizures co-existing with her epilepsy.Battery status indicator was reported to be normal.The change in seizure pattern and post-ictal duration is unclear if it is related to vns.It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.

Event Description

Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome.The patient reports that she has had increased seizures within the last year and does not feel the vns is working.The patient also stated she had a really rough week as she has had a lot of seizures.

Event Description

It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds.The stimulation was very strong and painful and making it difficult to swallow.She reported that generator location makes it difficult to access with the magnet to disable the device.It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time.Per the surgeon, the surgery was not to preclude a serious injury.No surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient underwent replacement due to battery depletion.The explanted product was returned.The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011.She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past.The patient's treating physician indicated that this patient was a high anxiety patient.It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events.Three reports regarding seizures of this patient were submitted since 2011.In mfr.Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation.The physician said that the patient's increased seizures were not related to vns.The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns.In (b)(6) 2015, mfr.Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted.This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns.Mfr.Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low." the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable.Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related.No further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.

Event Description

The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown.The patient's explanted product was discarded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6434722
• MDR Text Key: 70857917
• Report Number: 1644487-2017-03470
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2012
• Device Model Number: 102
• Device Lot Number: 2916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• 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): Required Intervention
• Patient Age: 47 YR