MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Energy Output To Patient Tissue Incorrect (1209); Fail-Safe Problem (2936); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2016

Event Type  malfunction  

Event Description

Information was received indicating that the patient reportedly attempted to disable the device with their magnet due to pain and the magnet did not turn off the stimulation.It is unclear if the patient left the magnet over the device for 65 seconds or not.The neurologist elected to disable the device for patient comfort.Prior to the disablement diagnostics were taken and settings were recorded.The diagnostic indicated that the patient's vns system was functioning properly.The lead impedance value was within normal ranges.No other relevant information has been received to date.

Manufacturer Narrative

Adverse event and/or product problem., corrected data: initial mdr erroneously had adverse event marked.

Manufacturer Narrative

Supplemental mdr inadvertently omitted information known prior to submission of the mdr.Supplemental #1 g4.Field should have stated (b)(6) 2016.

Event Description

Information was received which indicates that the surgeon used a nurolon 4/0 suture to secure the patient's generator to the pectoral fascia during the implant surgery.This type of suture is a nonabsorbable suture.No other relevant information was received regarding the migration of the patient's generator.

Manufacturer Narrative

Mfg.Report #0 inadvertently omitted information regarding the patient¿s car accident which was known prior to submission of the mdr.

Event Description

Information was received which indicated that the patient was in a motor vehicle accident in october 2015.During the accident the seatbelt was reportedly across the patient's chest.Following the accident the patient became concerned about the functionality of the vns device due to the previously reported pain.The patient requested to have the device removed however instead the physician opted to disable the device.Following the previously reported device disablement the patient did not see a change in seizure frequency.Therefore the physician agreed to remove the vns device per the patient¿s request.It was noted that the surgery was occurring for the patient¿s comfort.The patient then underwent lead and generator explant surgery.The explanted generator has not been received to date.

Manufacturer Narrative

Supplemental mdr #4 inadvertently omitted information known prior to submission of the mdr.

Event Description

The explanted lead and generator were received and are undergoing product analysis.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the generator.The generator was able to be interrogated and showed diagnostics that were within normal limits.The generator showed no signs of variation in the output or magnet signals and demonstrated the expected level of output and magnet currents when monitored for 24 hours.No functional anomalies were observed with the generator.Lead product analysis was also completed on the portion of the lead returned and no functional anomalies were found.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6015455
• MDR Text Key: 57105249
• Report Number: 1644487-2016-02209
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Model Number: 103
• Device Lot Number: 201604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2010
• 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 Age: 35 YR