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

Model Number 102

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Depression (2361); No Code Available (3191)

Event Date 01/09/2018

Event Type  malfunction  

Event Description

It was reported that the patient's vns was no longer working and the patient was in the er with increased symptoms of depression and may end up hospitalized.The physician was working on getting the patient referred for replacement surgery.The day prior to the report, the patient's generator was unable to be communicated with despite attempts with three different vns programming handheld devices.A battery life calculation estimated that the vns battery was not depleted, but a large gap existed in the data available to the manufacturer.No relevant surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Event Description

The explanted generator (initially reported to have been discarded) was received.Analysis was performed on the generator and it was determined that the battery was depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition.The device performed according to functional specifications of the current automated post burn test.Therefore, the electrical performance of the generator will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently left out information from the company representative.(b)(4).

Event Description

Follow up with the company representative revealed that the patient's vns generator battery was fully depleted and unable to be communicated with by the representative's programming equipment.The physician's programming handheld devices were confirmed as functioning properly and the failure to communicate with the patient's vns was due to the battery depletion.The patient was referred for vns generator replacement surgery.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently left out "it was reported that the patient was admitted in a facility for longer term evaluation/care due to his debilitating depression and suicidal thoughts." (b)(4).

Event Description

It was reported that the patient was admitted in a facility for longer term evaluation/care due to his debilitating depression and suicidal thoughts.The patient underwent vns generator replacement surgery.During attempts at product return, it was revealed that the device was discarded.

• 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: 7238951
• MDR Text Key: 99093638
• Report Number: 1644487-2018-00159
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 04/17/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2007
• Device Model Number: 102
• Device Lot Number: 014818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/08/2018; 03/08/2018; 03/23/2018
• Supplement Dates FDA Received: 02/19/2018; 03/29/2018; 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2006
• 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: 68 YR