MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Device Expiration Issue (1216); Electro-Static Discharge (2149)

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

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that diagnostic tests were taken on the generator prior to implanting of device outside of the pocket and after device was in the pocket.The test before implant showed the battery was not at near end of service condition, but the test after the generator was in the pocket showed that the device was at end of service condition.It was reported that the generator was not cold prior to implant.The physician decided to continue implanting the generator.The manufacturer's or specialist that attended the surgery did not see cautery come in contact with the generator, but the cautery device was lying on the patient when the generator was introduced.The surgeon also submerged the generator in a tray with antibiotic solution prior to implant.The manufacturer investigated the programming data available from surgery.The voltage dropped from 3.287v to 1.884v during the surgery.The initial interrogation (before implant) and system diagnostics were at ifi = no, and the subsequent diagnostics (after implant) measured between 1.884v and 1.988v.The drop in voltage is an indicator that the device likely came in contact with an electro-cautery device or an electrostatic discharge, causing the asic latch-up condition.Electro-cautery is known to potentially cause battery depletion and its usage is warned against in labeling.No known surgical intervention has occurred to date.

Event Description

It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5594516
• MDR Text Key: 44196789
• Report Number: 1644487-2016-00851
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

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: Health Professional
• Device Expiration Date: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 203335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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: 28 YR