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

Model Number 103

Device Problems Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Seizures (2063); Inadequate Pain Relief (2388); No Information (3190)

Event Date 01/10/2013

Event Type  Injury  

Event Description

It was reported by the surgeon the patient was going to have her vns explanted on (b)(6) 2016.The surgeon stated the patient had been implanted for over 3 years and the vns was not effective because the patient wasn't able to tolerate titrating up the vns settings.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported the patient had requested for the device to be explanted because she didn't like it and it wasn't helping her.It was noted the device was programmed off because the patient didn't like the current, but then she just didn't like the vns.There were no issues with the vns, the patient just did not like it and requested the explant.It was later verified the patient's vns was explanted on (b)(6) 2016.

Manufacturer Narrative

This information was inadvertently left off of the supplemental #01 mfr.Report.(b)(4).

Event Description

It was later reported by the same physician that the adverse events the patient experienced during titration included pain in the neck, difficulty swallowing, uncomfortable when the current is programmed on, increased falls during her seizures, and no decrease in seizures activity.It was also noted that the patient's seizures were possibly worse with vns; however, no actual seizure rates were given.

Event Description

It was reported by the explanting facility that the device was discarded.

Manufacturer Narrative

This information was inadvertently left off of supplemental #03 mfr.Report.

Event Description

It was initially reported by the explanting site that the vns devices had been discarded; however, additional information was received from the site and they had requested the return number so that they could send the generator back.The generator and a portion of the lead were returned to the manufacturer.While analysis is expected, it has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis (pa) for the returned generator was completed.The device performed per functional specifications.There were no performance or any other type of adverse conditions found with the generator.Pa for the returned lead was completed.Note that the lead assembly (body) including a portion of the connector boot; therefore, a complete evaluation could not be performed on the entire lead product.The condition of the returned portion of the lead was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.

• 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: 6181099
• MDR Text Key: 62592878
• Report Number: 1644487-2016-02892
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/07/2017

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: 05/31/2014
• Device Model Number: 103
• Device Lot Number: 202155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: 4 YR
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/10/2017; 01/13/2017; 01/25/2017; 01/27/2017; 03/28/2017; 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• 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: 35 YR