MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Energy Output Problem (1431)

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

Event Date 02/13/2019

Event Type  malfunction  

Event Description

It was reported that patient had an appointment, the device was interrogated and the normal mode output current was set to 0.00 ma while the magnet mode current was still set to 2.00 ma.The np stated that the patient's device was not turned off at the time of the event in february.The facility cannot determine whether the patient's device has been turned off since february, they have decided to start the patient back up at lower levels and titrate the patient up slowly.She stated that diagnostics were run and were within normal limits.Programming history was reviewed and had settings from february and april appointments.It is seen that the last event in february was a programming event to 1.75ma and when the patient came in april the settings were at 0ma.There is no indication form the settings of a faulted diagnostic test that may have unintentionally changed settings.There is a two month gap where the patient may have potentially been seen by a different physician and programmed to these settings however this needs to be confirmed.Other than the note anomaly above, no other anomalies were noted.No additional relevant information has been received to date.

Event Description

Information was received that the patient was not seen at any other facility or interrogated/programmed with any other tablet/device.No additional information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8599052
• MDR Text Key: 145114450
• Report Number: 1644487-2019-00894
• 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
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2015
• Device Model Number: 102
• Device Lot Number: 202608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2013
• 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: 58 YR