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

Model Number 1000

Device Problems False Alarm (1013); High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

It was reported that patient was seen in clinic because of an increase in seizures.Upon interrogation of the device, high impedance of 5391 ohms was detected, which is just over the 5300 ohms trigger for high impedance.Follow-up with the nurse practitioner found that there was no trauma to the vns just prior to the onset of the high impedance.The patient was having increased seizures, but the patient had no known change in perception of vns stimulation.Medications were changed in response to the patient's seizures.X-rays were received and reviewed but that quality of the images were too poor to assess continuity of the leads or complete pin insertion.The manufacturer's programming history database for the patient's generator was reviewed and it was found that the generator was close to 5300 ohms, since a month after explant.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators.As indicated in the physician's manual, high lead impedance (>/=5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient underwent generator replacement due to the high impedance detected.Impedance was 5202 ohms pre-op and was still at that level with pin insertion.With the new generator (not impacted by higher impedances firmware as discussed in previous report), it was 3935 ohms.No further relevant information has been received to date.The explanted producthas not been received to date.

Event Description

Product analysis was completed on the returned generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.No anomalies were identified.

Event Description

The explanted generator was received for analysis, but analysis has not been completed on the returned product to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11286948
• MDR Text Key: 232169256
• Report Number: 1644487-2021-00189
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2020
• Device Model Number: 1000
• Device Lot Number: 204743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/12/2021; 03/22/2021; 04/21/2021
• Supplement Dates FDA Received: 03/10/2021; 04/16/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR