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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Depression (2361)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

Additional information was received that the patient underwent generator and lead replacement surgery due to the reported high impedance.The high impedance was still seen prior to surgery.It was reported that the lead was completely fractured in two when it was explanted.The explanting facility will not be returning the explanted generator or lead to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Evaluation codes; corrected data: the previously submitted mdr inadvertently provided the wrong conclusion code number.Device failure suspected, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that the patient's device was programmed off and the patient underwent brain resection.The patient continued with seizures and depression so the vns was programmed back on; however, device diagnostics resulted in high impedance (dc dc 7).The patient was referred for surgery.

Manufacturer Narrative

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

• 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: 4555010
• MDR Text Key: 5726763
• Report Number: 1644487-2015-04003
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2005
• Device Model Number: 302-20
• Device Lot Number: 009342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2003
• 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: 52 YR