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

Model Number 106

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

It was reported that the patient was replaced less than 2 months ago and battery is already at 11% and showing low impedance.An image of the warning message received for the low impedance was provided however indicated that a generator diagnostics had been performed, therefore, the low impedance message is expected as it is only supposed to be used with a test resistor in the operating room.Neurologist sent patient for consult with surgeon however surgeon's office checked battery as was okay.No known surgery for the event has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that patient is now referred for replacement due to an unknown reason.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information ; initial mdr inadvertently omitted information known prior to submission d6b.If explanted, give date; corrected information; initial mdr inadvertently omitted information known prior to submission f10.Adverse event problem; corrected information; initial mdr inadvertently omitted information known prior to submission h6.Adverse event problem codes; corrected information; initial mdr inadvertently omitted information known prior to submission.

Event Description

It was reported that patient had been explanted due to prophylactic reasons per implant card.No known relevant surgical intervention has occurred to date.The explanted devices have not been received for analysis to date.

Event Description

The suspect product was noted to be discarded.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11913009
• MDR Text Key: 253529414
• Report Number: 1644487-2021-00742
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2022

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: Lay User/Patient
• Device Expiration Date: 02/09/2023
• Device Model Number: 106
• Device Lot Number: 205472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/07/2022; 07/25/2022; 09/28/2022
• Supplement Dates FDA Received: 06/30/2022; 07/25/2022; 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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: 63 YR
• Patient Sex: Male