MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 07/29/2015

Event Type  malfunction  

Event Description

It was reported that high lead impedance was registered on the patient's generator during a generator replacement surgery.Surgery to address the high impedance has not occurred to date.Attempts for additional pertinent information have been unsuccessful to date.

Event Description

The explanted generator was received by the manufacturer for product analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process.No other surface abnormalities were noted on this device or the internal printed circuit board.Review of the internal data from the pulse generator showed indications of increased impedance during device implant.On (b)(6) 2015, the impedance changed from a pre-change value of 7561 ohms to a post-change value of 9924 ohms.The device was returned in a pulse disabled condition that was due in part to the increased impedance which required a higher output voltage.The pulse disabled status of the generator would not reset.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 1.762 volts, confirming an end of service battery condition.The internal device data revealed that 85.109% of the battery had been consumed.Electrical tests results show that the pcba performed as expected and passed all required quality tests.Other than the evidence of high impedance and its contribution to the end of service of the generator, there were no additional performance or any other type of adverse conditions found with the pulse generator.No additional pertinent information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 6216887
• MDR Text Key: 63691692
• Report Number: 1644487-2016-02961
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2017

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: 06/30/2014
• Device Model Number: 304-20
• Device Lot Number: 2725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2017; 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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: 14 YR