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

Model Number 302-20

Device Problems High impedance (1291); Malposition of Device (2616)

Patient Problem Seizures (2063)

Event Date 02/08/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.The physician indicated that the patient reported an increase in seizures since about twenty days ago.The patient was sent for x-rays.X-rays were sent to manufacturer for review.No lead breaks or sharp bends were identified.The lead pin did not appear to be fully inserted into the generator header; however, due to the quality of the images this could not be determined.Attempts to obtain additional information have been unsuccessful to date.Surgical intervention has not occurred to date.

Manufacturer Narrative

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

Event Description

Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.The patient also was experiencing an increase in seizures.

Manufacturer Narrative

The initial manufacturer report inadvertently did not include all of the available information regarding the event.

Event Description

It was reported that the patient underwent generator and lead replacement.It was reported that the generator was replaced prophylactically.The explanted devices have not been received for analysis to date.

• 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: 3710038
• MDR Text Key: 4263126
• Report Number: 1644487-2014-00826
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2014

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: 09/30/2014
• Device Model Number: 302-20
• Device Lot Number: 2792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/22/2014; 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• 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: 8 YR