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

Model Number 106

Device Problems Premature Discharge of Battery (1057); Premature Indicator Activation (3011)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the nurse practitioner was concerned because the patient's battery life indicator already indicated 25% battery life on (b)(6) 2016.The generator was implanted a little over a year earlier on (b)(6) 2015.The generator device history record was reviewed and found all specifications were met prior to distribution.System diagnostics performed (b)(6) 2016 confirmed that the device was operating within normal limits.The internal device data found that during the final system diagnostic test performed on (b)(6) 2016 the charge consumed was 15.618% and battery voltage was noted to be 2.863v, the registered indicator indicated 25% battery remaining at this time.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

It was identified through an internal investigation that the observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths.This finding is indicative that the generator will reach true end of service earlier than expected.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's device had reached ifi=yes, battery indicator.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient had generator replacement surgery.The generator has not been received to date.

Event Description

Generator product analysis was completed.The premature end of life, or eol, allegation was confirmed in the product analysis, or pa, lab.Communication with the generator was not possible and, therefore diagnostics, vbat calculation and the fet could not be performed.With the generator case removed and the battery still attached to the printed circuit board assembly, the battery measured 0.00016 v, confirming the eos condition.The pcba was subjected to a postburn electrical test and the results indicated that the pcba failed several electrical tests.Contaminates were observed on the trimmed edge of the pcba and removed with the use of fine grit sand paper and isopropyl alcohol.The observed contamination suggests probable electrical paths were established between the copper edges on the trimmed edge of the pcba, which resulted in out of specification increased current consumption for both standby and pulsing operation modes.

Event Description

The vns generator was received by the manufacturer and is pending product analysis.

• 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: 6031665
• MDR Text Key: 57628444
• Report Number: 1644487-2016-02328
• 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 Assistant
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2017
• Device Model Number: 106
• Device Lot Number: 203410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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: 42 YR