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

Model Number 1000C

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  malfunction  

Event Description

It was reported that the patient¿s battery was at near end of service 6 months post implant.It was indicated that the patient did not had any procedure since implant that would expose them to electrocautery or other electrical devices; however, the patient is an electrician and works in construction sites.The patient indicated that he works with low voltages and the power is almost always off.No known surgery has occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Event problem ¿ correction ¿ inadvertently did not include in supplemental mdr #01 d9.Device available for evaluation? ¿ correction ¿ inadvertently did not include in supplemental mdr #01 d3.Device evaluated by mfr? ¿ correction ¿ inadvertently did not include in supplemental mdr #01 h6.Adverse event problem codes ¿ correction ¿ inadvertently did not include in supplemental mdr #01.

Event Description

The generator was received for analysis and is currently ongoing.No additional relevant information has been received to date.

Event Description

Additional information was received that the patient is no longer able to feel stimulation and don't feel anything happens when they swipe their magnet.It was confirmed that the patient's battery has been replaced.The explanted generator has not been received to date for analysis.At this time, no additional relevant information has been received to date.

Event Description

Product analysis (pa) for the returned generator was completed.The reported allegations of neos = yes was duplicated in the pa lab, due to a depleted battery.At the pa bench, the pulse generator would not interrogate.Therefore, the diagnostic vbat calculation, system diagnostics, and final electrical test could not be performed.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 1.834 volts (neos range 2.72v - 2.19v), confirming an eos=yes condition.A visual assessment on the pcba showed no visual anomalies.The reported allegations of premature battery depletion was not duplicated in the pa lab.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.The electrical performance of the generator was used to conclude that no anomalies exist, and the end-of-service (eos) condition is an expected event.Other than the noted event of no communication, there were no additional performance, or any other type of adverse conditions found with the pulse generator.

Event Description

Further investigation was performed on the cause of the premature depletion.After further evaluation, the cause of premature end of life is unknown.There is no failure in performance when tested in product analysis, but there was confirmed failure of the device since premature end of life was confirmed.Most likely cause is manufacturing error.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000C
• 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: 11222740
• MDR Text Key: 228453761
• Report Number: 1644487-2021-00094
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/07/2022

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: 03/04/2021
• Device Model Number: 1000C
• Device Lot Number: 205117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 02/16/2021; 04/06/2021; 10/13/2022
• Supplement Dates FDA Received: 02/16/2021; 03/08/2021; 04/30/2021; 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• 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: 42 YR
• Patient Sex: Male