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

Model Number 1000

Device Problems Erratic or Intermittent Display (1182); Premature Elective Replacement Indicator (1483)

Patient Problems Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

Additional information was received that when high impedance was first seen, battery was ok however at following visits, the battery % fluctuated and is now at ifi with patient on rapid cycling.The fluctuating battery status is being reported in mfr report.The high impedance was already reported in mfr report # 1644487-2021-00143.No known surgery has occurred to date.No additional information has been received to date.

Manufacturer Narrative

B5.Event description ¿ correction ¿ inadvertently did not include in the initial mdr submitted.F10.Health effect ¿ clinical code ¿ correction ¿ inadvertently did not include in the initial mdr submitted.

Event Description

Additional information was received by the patient's caregiver that the patient was having ambulation difficulties they suspect to be related to the battery depletion.The event was also reported under mfr report #1644487-2021-00143 however will be reported and coded under this report as alleged to the battery depletion.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Patient has been referred for a full revision.No surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received that patient underwent generator replacement.The patient¿s device showed end of service (eos) equals yes with pulse disabled along with high impedance.During surgery the surgeon removed the old generator and did not visually observe any issues with the generator or the lead.The replacement generator showed ok impedance.Pt's head was rotated right and left and diagnostics were checked to rule out micro-fractures with settings all showing normal.Lead was also pulled out as much as possible, diagnostics were checked, and settings were all normal.Lead left implanted with new generator.Pt was then closed, diagnostics were ran, and settings were all normal.The explanted device was sent to pathology.Explanted product has not been received to date.No additional relevant information has been received to date.

Event Description

Explanted product was received into product analysis.Product analysis was completed.The generator would not interrogate.The in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area passed.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block.The measure battery voltage confirmed eos condition.Other than the no communication (due to eos), the device performed according to functional specifications and there were no performance, or any other type of adverse conditions found with the pulse generator.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13193899
• MDR Text Key: 284356411
• Report Number: 1644487-2022-00014
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/09/2023

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: 03/10/2022
• Device Model Number: 1000
• Device Lot Number: 205309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 02/01/2022; 02/02/2022; 05/17/2022; 08/02/2022; 12/19/2022
• Supplement Dates FDA Received: 02/01/2022; 02/02/2022; 06/10/2022; 08/26/2022; 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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: 61 YR
• Patient Sex: Male