MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Failure of Device to Self-Test (2937); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported that this vns patient's generator was explanted on (b)(6) 2014 because the generator failed during testing.Follow-up showed that no troubleshooting was recorded in the operative note.Per the surgeon's office, the device was successfully communicated with on (b)(6) 2013 (date of implant) at which time, the device was not programmed on.The explanted generator has been returned to the manufacturer where analysis is currently underway.Review of manufacturing records confirmed that the suspect device passed all functional tests prior to distribution.

Event Description

The information available indicates that the exposure to electrocautery occurred at the time of explant, not implant.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr indicated that burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant; however, this should have reflected that the exposure occurred at device explant.This report is being submitted to correct this information.

Manufacturer Narrative

Review of the available programming/diagnostic history and decoder data.

Event Description

Analysis of the returned generator was completed.A failure was noted in the output circuit of the generator to deliver a pulse between the positive and negative electrodes.The no output condition was due to a failure of the asic to deliver a pulse on the positive output pin.Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant.The no output condition is possibly due to damage by the use of electro-cautery.It also noted that the battery was swollen, indicating that the generator was in a high current state at one point.Review of the available programming and diagnostic history along with the decoder data from the generator replacement procedure on (b)(4) 2013 showed that the final system diagnostic test performed that day had the pulse status as enabled, indicating that the pulse disablement likely occurred due electrocautery used during the explant procedure on (b)(4) 2014.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3965041
• MDR Text Key: 4608096
• Report Number: 1644487-2014-01846
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 105
• Device Lot Number: 202613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2013
• 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: 11 YR