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

Model Number 1000

Device Problems Premature End-of-Life Indicator (1480); Communication or Transmission Problem (2896)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

It was reported that during the generator replacement surgery, the newly implanted generator was not able to be interrogated, after being interrogated 2 mins prior.The rep tried hold the wand directly over the generator, tried bluetooth and wired connection, reset the tablet, reset the generator, emi was minimized by turning off or lights and moving away from emi.The patients explanted generator was able to be interrogated in the same spot as the suspect generator.The rep noted that electrocautery was not used, but was not sure if it was in the vicinity.The suspect generator was not used and new generator was able to be interrogated and was implanted.The suspect product has not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the suspect generator.Visual examination performed at the bench revealed a burn marks on generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant.This would indicate that the generator was probably in a high current state, asic latch-up condition.This resulted in the observed ¿failure to program¿ condition.Electrical test results showed that the pulse generator performed according to functional specifications.

• 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: 10437524
• MDR Text Key: 203867787
• Report Number: 1644487-2020-01103
• 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
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 1000
• Device Lot Number: 205213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Event Location: Other
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR