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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

It was stated that the patient generator could not be turned back on.The physician state he was trying to titrate the patient settings and was getting an error message.It was noted that error code 254 was also being reported when attempting to run system diagnostics, which is associated with reed switch closure/failure on m1000 generators.It was stated by the physician that the patient had recently had a surgical procedure unrelated to vns and the vns magnet was used to inhibit stimulation for the duration of the surgery.It was noted that the patient was not feeling stimulation after the surgery, which is why the physician was attempting to increase settings.Magnet swipes were also not perceived by the patient.Generator reset was performed.When the generator was reinterrogated, error code 4 and lead impedance low were observed.The internal data was reviewed and it was determined that the patient was in a stim inhibited state during interrogation, indicating that the reed switch of the generator was closed even though a magnet was not present.At a previous appointment on (b)(6) 2020, the generator was in a normal state ("stim in offtime").On 11/9/2020, therapy run state was observed to be in stim inhibited when a magnet was not present.The manufacturer's device history records of the m1000 were reviewed.The generator passed final functional and quality specification prior to release.No known surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Patient had a generator replacement occur.The explanted generator has not been received to date.No additional relevant information has been received to date.

Event Description

Generator was received and product analysis was performed.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations were performed during output monitoring and demonstrate the appropriate magnet current for the programmed settings.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Programming data showed 7 magnet stimulation inhibition events and 16 magnet holds which are likely related to the reed switch failure.Product analysis finding no anomalies with a generator does not rule-out reed switch failure.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: 10949684
• MDR Text Key: 220249774
• Report Number: 1644487-2020-01627
• 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
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2021
• Device Model Number: 1000
• Device Lot Number: 205293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Event Location: Other
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR