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

Model Number 1000

Device Problems Mechanical Problem (1384); Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported that the patient had low output current observed and could not feel stimulation.The patient was seizure free since implant and was now having seizures again.Xrays were performed.Low impedance was observed after system diagnostics were performed.Xray review was performed.The connector pin of the lead was not observed past the second connector block.The back of the connector pin was observed to be out further than normally be expected.The notches in the middle of the connector pin were not observed in the typical location.Based on the images provided, it was confirmed that incomplete lead pin insertion has occurred.It was reported that revision surgery was performed.In the surgery, the generator was tested with a test resistor and impedance was measured as approximately 4000 ohms.The lead was re-inserted into the generator and observed pasted the connector block.The generator was tested and impedance was observed to be within normal limits.The generator was tested several times and no impedance issues were observed.Post-op impedance was also observed to be within normal limits.The generator was reimplanted as the impedance issues resolved with lead pin reinsertion.No additional relevant information has been received to date.

Event Description

It was reported that the patient's lead pin was reinserted and impedance was observed to be within normal limits during and in post-op.During the surgery, the lead pin was observed to have been passed the connector block.Generator was tested with resistor pin and found to be properly functioning.It was reported that two weeks later the patient was unable to feel stimulation and low impedance was observed again.Patient had a lead revision performed on (b)(6) 2020.After the lead revision, two weeks went by and the patient passed their magnet over the generator and no stimulation was felt.The patient was interrogated and normal impedance was observed; however, low output current was observed.System diagnostics were performed and low impedance occurred.Generator reset was performed and low impedance persisted.Generator was able to programmed normally and the patient was programmed off.No error messages were noted to have been observed.The patient was noted to not be a twiddler.Tablet data was downloaded and sent in for review to confirm.Decoder review or the generator was completed.A "stim inhibited" condition was confirmed, and it persisted even after the magnet was removed from over the generator, indicating that the reed switch was likely stuck closed.The generator reset was performed on, and the generator was reinterrogated and found to be in a "stim stopped" condition.Diagnostics following this generator reset showed low impedance, which is further indicative that the reed switch is stuck in a closed position.It is suspected that the intermittent low impedance from the generator reed switch failure occurred due to the manipulation of the generator during surgery.From the manipulation it is suspected that the reed switch became dislodged from a closed position and allow normal impedance readings and function.The reed switch would then become stuck in the close position once again leading to low impedance.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received.

Manufacturer Narrative

F10.Event problem - device code - correction - code 1431 should have been used on the initial mdr.

Event Description

Product analysis (pa) was completed on the returned generator.The reed stuck closed was not duplicated in the pa lab.Results of monitoring, magnet applications, and diagnostic testing indicated the device was operating properly and communicated properly.No functional anomalies were observed in pa.Pa finding no anomalies with a generator does not rule-out reed switch failure.It is suspected that the intermittent low impedance from the generator reed switch failure occurred due to the manipulation of the generator during surgery.From the manipulation, it is suspected that the reed switch became dislodged from a closed position and allow normal impedance readings and function for some time.The reed switch would then later become re-stuck in the close position once again leading to low impedance and loss of perception of stimulation.No additional relevant information has been received to date.

Event Description

It was reported the patient had a generator replacement.The replacement generator was noted to be properly functioning.The explanted generator was returned.Product analysis is being performed.No additional 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: 10817352
• MDR Text Key: 215529364
• Report Number: 1644487-2020-01502
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2022
• Device Model Number: 1000
• Device Lot Number: 205171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Event Location: Other
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention