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 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's device was already at 25% battery status.The device was at 100% battery status in (b)(6) 2016.No further relevant information has been received to date.

Event Description

Programming data was reviewed.The impedance was within normal limits throughout the available history.The charge consumed was too low for the battery voltage to be at 25%.Longevity tables estimated between 9.5 and 6.8 years at 33% and 50% duty cycles, respectively, from beginning of life until ifi=yes.Since the battery was already at 25% after less than 1 year, the device appears to be depleting more quickly than expected.The premature battery depletion was most likely due to the manufacturing method used.

Event Description

The patient underwent vns generator replacement surgery.The explanted generator has not been received by the manufacturer to date.

Event Description

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

Event Description

Generator product analysis was completed.The reported premature end of life was duplicated in the product analysis, or pa, lab.The vns generator, as received, would not interrogate and, therefore, the data could not be downloaded from the generator and the diagnostic vbat calculation, diagnostics, the final configuration r-wave test, and fet could not be performed.With the generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 0.176 v, confirming an end of service, or eos, condition.The pcba was subjected to postburn electrical tests and failed several electrical tests.Sandpaper was used to remove the observed contaminates from the trimmed edge of the pcba.The observed contamination on the trimmed edge suggested probably electrical paths established between the copper edges of the trimmed edge of the pcba, contributing to the supply current conditions.Remaining residual material on the pcba edge after test tab removal during manufacturing resulted in increased out of specification current consumption for both standby and pulsing modes.This may have been a contributing factor for the reported premature end of life.

• 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: 6172271
• MDR Text Key: 62681882
• Report Number: 1644487-2016-02853
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2017
• Device Model Number: 106
• Device Lot Number: 4407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 12 YR