MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNKNOWN

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent a lead replacement due to high impedance on (b)(6) 2015.The existing generator was tested upon connection to the new lead and system diagnostics returned high impedance, reported in the mfr.Report #1644487-2015-05010.A new generator was implanted as a replacement and system diagnostics on the new device returned impedance within normal limits.Further information was received indicating that the previous lead was not explanted, but the new lead was implanted on the right vagus nerve.No x-rays had been taken.No known further surgical interventions have occurred to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 4867412
• MDR Text Key: 6061872
• Report Number: 1644487-2015-05011
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/25/2015
• 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 Age: 19 YR