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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/08/2013

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2013.High impedance was again observed on (b)(6) 2013 and (b)(6) 2014.Further follow-up revealed that the patient was seen for increased seizures and high impedance.X-rays were taken and showed a lead fracture.It was reported that the patient underwent lead replacement and is now doing well.It was reported that possible trauma caused the lead fracture although this could not be guaranteed.The device was not disabled after observing the high impedance as the patient did not show discomfort.

Manufacturer Narrative

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

Event Description

Additional information was received that the explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

• 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: 4541076
• MDR Text Key: 17997086
• Report Number: 1644487-2015-03959
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• 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): Required Intervention
• Patient Age: 12 YR