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

Model Number 303-20

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

Patient Problem Fibrosis (3167)

Event Date 03/14/2018

Event Type  Injury  

Event Description

It was reported by the company representative that a surgeon was having difficulty placing the lead on the nerve.The surgeon wanted to use a clip on the electrode to secure it to surrounding soft tissue.The surgeon had claimed that the nerve looked ¿ragged¿ and was the reason the electrode was having difficulty staying in position.Additional relevant information has not been received to-date.

Event Description

Follow-up from the surgeon provided that the nerve was scarred from the previous vns lead.The scarring around the nerve was associated with the presence of the device and was expected.The clips were used to secure the lead coils around the thickened, scarred nerve.The physician stated the longer lead may have been helpful, but was not available that day.The clips were used to prevent the coils from slipping off the nerve.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: LEAD
• 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: 7403413
• MDR Text Key: 104588377
• Report Number: 1644487-2018-00525
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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
• Report Date: 04/30/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2021
• Device Model Number: 303-20
• Device Lot Number: 204079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR