MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Battery Problem: High Impedance (2947)

Patient Problem Chest Pain (1776)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.The patient reported pain in the chest area during device stimulation.The device was programmed off after observing the high impedance.The patient was referred for x-rays.The patient has been referred for surgery.No known surgical interventions have been performed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

It was reported that the patient underwent lead and generator replacement on (b)(6) 2015.It was reported that a keloid had developed around the explanted lead.The generator was replaced prophylactically.It was reported that the explanted lead was discarded.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.The explanted devices have not been returned to date.

Manufacturer Narrative

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

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Adverse event or product problem; corrected data: the previously submitted mdr inadvertently provided incomplete information, as it did not specify that the event was both an adverse event and product problem.Outcomes attributed to adverse event; corrected data: the previously submitted mdr inadvertently provided incomplete information.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4664846
• MDR Text Key: 5621767
• Report Number: 1644487-2015-04394
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2008
• 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): Other; Required Intervention
• Patient Age: 10 YR