MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

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

Event Date 02/08/2019

Event Type  malfunction  

Event Description

It was reported that high impedance was observed on the patient's vns.It was believed that the ent surgeon who performed exploratory surgery to investigate a bulge in the patient's neck had nicked the vns lead.The bulge was revealed to the protrusion of a vns lead tie-down.Follow up with the medical professional revealed that the high impedance was the result of the exploratory surgery as the impedance was within normal limits prior to the surgery.It was reported that the exploratory surgery was to preclude serious injury as it was to explore a left neck nodule.However, as the date was not provided for the lead impedances prior to the surgery, it cannot be confirmed that the diagnostics pre-operatively were within normal limits.The protrusion of the vns tie-down is reported in mfg.Report #1644487-2019-00448.The patient underwent vns lead replacement surgery.During product return attempts, it was revealed that the facility, historically, does not return explanted products and discards in surgery.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8404308
• MDR Text Key: 138273251
• Report Number: 1644487-2019-00447
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Other
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2018
• Device Model Number: 304-20
• Device Lot Number: 203155
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• 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: 54 YR