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

Model Number 302-20

Device Problem Low impedance (2285)

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

Event Date 11/11/2008

Event Type  malfunction  

Event Description

It was reported that a patient was having generator replacement surgery, and low impedance was noted at the time of replacement on both the old and new generators.The pin was re-inserted, and diagnostics were performed with the same results.Heart rate detection was verified to have a good detection at sensitivity 1.The surgeon decided not to replace the lead since the previous impedance was dcdc = 0.The patient's device was programmed per the physician's orders.The patient did feel stimulation prior to surgery.The device history record of the lead was reviewed, and the lead passed all functional specifications prior to release.Revision surgery has not occurred to date.

Event Description

The explanted generator has not been received to date.

Event Description

The explanted generator was received on 04/19/2016 and analyzed on 05/02/2016 and was found to be conforming to all manufacturer specifications.There were no malfunctions found with the explanted generator.

• Brand Name: LEAD MODEL 302
• 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: 5436424
• MDR Text Key: 38873947
• Report Number: 1644487-2016-00312
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2006
• Device Model Number: 302-20
• Device Lot Number: 009728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2003
• 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: 41 YR