MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 304

Model Number 304-20

Device Problems Degraded (1153); Disconnection (1171)

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

Event Date 04/19/2016

Event Type  malfunction  

Event Description

It was reported that a vns patient underwent full replacement surgery on (b)(6) 2016.It was reported that the lead was replaced due to lead discontinuity.The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with 2878 ohms.Further information was received indicating that the generator was prophylactically replaced.It was reported that the explanted devices will not be returned to the manufacturer; therefore, no analysis could be performed.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.No additional relevant information was provided to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 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: 5678262
• MDR Text Key: 47237826
• Report Number: 1644487-2016-01126
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2016

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: 09/30/2016
• Device Model Number: 304-20
• Device Lot Number: 3429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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 Age: 16 YR