MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature Discharge of Battery (1057)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient¿s generator battery showed approximately 25% remaining prematurely.It was reported to have previously registered at almost 100% in (b)(6) of 2016.The generator device history record was reviewed and found that all specifications were met prior to distribution.The internal device data was reviewed.The review showed that no anomalies were noted on the date of implant ((b)(6) 2015).The battery indicator at that time was showing 100%.Review of the data on (b)(6) 2016 showed that the battery voltage was between 2.860v ¿ 2.865v, and the charge consumed value was between 12.612 ¿ 12.613%.The indicator shown at that time was 25% remaining.All impedance values were within normal limits.The data showed 24018 autostimulations had been delivered by that time.The minimum battery registered up until that date was 2.860v that was recorded on (b)(6) 2016.No additional pertinent information has been received to date.

Event Description

It was reported that the patient¿s generator still registered a 25% battery indicator when he was seen for a clinical visit on (b)(6) 2016.The patient was planned to undergo a replacement surgery.However, no surgical intervention has occurred to date.No additional pertinent information has been received to date.

Manufacturer Narrative

Date received by manufacturer, corrected data: follow-up report #1 inadvertently listed the wrong date, which was supposed to be 11/23/2016.(b)(4).

Event Description

Internal investigation has shown that this incident of a 25% battery indicator was likely caused by conductive debris from the laser-routing process resulting in leakage paths.Based on this root cause and analysis of returned devices, the premature 25% battery life indicators are typically indicative that the generator will reach true end of service earlier than expected.A secondary cause for premature 25% battery life indicators in a small subset of associated generators may be high beginning of life (bol) battery impedance.Generators only affected by this secondary root cause would be expected to rebound back to normal battery life levels without substantial programming changes.

Event Description

The patient¿s generator replacement surgery was completed on (b)(6) 2017.The generator was reportedly discarded by the explanting facility, so product return to the manufacturer is not expected.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6046797
• MDR Text Key: 58460557
• Report Number: 1644487-2016-02400
• 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,Followup
• Report Date: 07/03/2017

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: 07/08/2017
• Device Model Number: 106
• Device Lot Number: 4410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/14/2017
• Supplement Dates FDA Received: 12/09/2016; 12/15/2016; 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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: 13 YR