MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems Premature Discharge of Battery (1057); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported that this vns patient was referred for generator revision for an unknown reason.On (b)(6) 2014, a tc present at the patient¿s appointment preformed diagnostics: diagnostics were within normal limits.The generator was reported to be being replaced due to generator nearing end of service.The patient underwent generator revision on (b)(6) 2015.The generator was returned and underwent product analysis.Analysis was approved on (b)(6) 2015 and identified that the generator had reached a near end of service state sooner than expected based on a battery life calculation and an analysis of the generator¿s charge consumption counter.A review of the generator¿s device history record revealed that it was likely left programmed on to a high output state as a result of an incomplete final electrical test (fet) at the time of manufacture.The generator likely stayed in this high output state for months before being subjected to fet again, effectively programming the generator off.During the time in between fet tests, the generator is believed to have used a significant amount of battery capacity, resulting in the discrepancy identified in product analysis.There were no additional performance or any other type of adverse conditions found with the pulse generator.Review of the dhr shows that the device did pass all functional specifications prior to distribution.Review of in-house programming history shows that the ifi-indicator was first seen on (b)(6) 2014.

Manufacturer Narrative

Programming history and device history records were reviewed.No device failure occurred; however, the device did reach an end of life condition earlier than expected due to the generator remained programmed to a high output state during manufacturing.The event did not cause or contribute to a death or serious injury.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• 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: 4618213
• MDR Text Key: 17221865
• Report Number: 1644487-2015-04023
• 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: Other
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2014
• Device Model Number: 104
• Device Lot Number: 3402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 001-C
• Patient Sequence Number: 1
• Patient Age: 49 YR