MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-30

Device Problems High impedance (1291); Inadequacy of Device Shape and/or Size (1583); Battery Problem (2885)

Patient Problems Fibrosis (3167); No Code Available (3191)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that during generator replacement for end of service, high impedance was observed prior to replacing the generator.The surgeon removed and reinserted the lead pins into the generator header to ensure the high impedance was not caused by a generator/lead connection issue; however, device diagnostics again resulted in high impedance.A new generator was implanted and connected to the existing lead and again device diagnostics resulted in high impedance.The surgeon then replaced the lead and device diagnostics were within normal limits.It was reported that a smaller diameter lead was placed and that the surgeon believed the cause of the high impedance was due to too large of a lead placed on the nerve which resulted in an excess amount of fibrosis.The explanted devices were reported to have been sent to pathology; however, pathology reported that the explanted devices were never received.The explanted devices have not been received for analysis to date and were likely discarded during the surgery.

Manufacturer Narrative

Device failure is 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
• 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: 4906044
• MDR Text Key: 16908610
• Report Number: 1644487-2015-05141
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2008
• Device Model Number: 302-30
• Device Lot Number: 015227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2006
• 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: 63 YR