MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Mechanical Problem (1384)

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

Event Date 12/09/2019

Event Type  malfunction  

Event Description

It was reported that when interrogating the patient's device, a low output current message was seen.Diagnostics were then attempted and error code 254 was seen.The following troubleshooting steps were performed: the wand was programmed on and off, the wand was reset, another tablet and wand were tried, the tablet was tried with another wand and the wand was tried with another tablet, and a wired connection was also performed.None of these troubleshooting steps resolved the issue.A generator reset was then performed.A review of the internal data of the generator found that there were no magnet activations and autostimulations since (b)(6) 2019.The manufacturer's device history records of the generator were reviewed.The generator passed final functional and quality specification prior to release.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received noting that the generator was explanted.Explanted generator was returned for product analysis.No other relevant information has been received to date.

Event Description

Generator analysis was completed.The reed switch stuck closed was confirmed in the product analysis lab.Review of the magnet status indicated 86 magnet holds and 300 magnet swipes.Which could indicate that the reed switch was stuck during the implant.Bench testing in the pa lab confirmed that the reed switch was stuck closed.This was verified by the programming the device to a magnet output and applying magnet.No magnet output was observed when the magnet was removed.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9548364
• MDR Text Key: 183511318
• Report Number: 1644487-2020-00030
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: 1000
• Device Lot Number: 204992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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: 60 YR