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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 11/21/2017

Event Type  malfunction  

Event Description

It was reported that a vns patient was referred for replacement due to battery depletion however the device had not been implanted for a full year at the time of referral.The downloaded programming data was reviewed.The data on (b)(6) 2017 shows that the voltage dropped to 2.105 volts from 3.378 volts and displayed a near end-of-service-condition.The voltage was then shown to have recovered on (b)(6) 2017 to 3.445 volts and was no longer at a near end-of-service-condition.The lead impedance was within normal limits at 2,144 ohms and 1,205 ohms (b)(6) 2017 and (b)(6) 2017 respectively.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Generator replacement surgery occurred.The explanted device was discarded by the hospital.

Manufacturer Narrative

Event description, corrected data: it was inadvertently not provided on the initial report that the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017.Event codes, corrected data: the event codes were inadvertently provided incorrectly on the initial report.

Event Description

From review of the data available, the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017.

• 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: 7135315
• MDR Text Key: 95656320
• Report Number: 1644487-2017-05056
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2018
• Device Model Number: 106
• Device Lot Number: 203885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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: 33 YR