MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Communication or Transmission Problem (2896)

Patient Problem Seizures (2063)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

It was reported that the patient's device could not be interrogated with two different programming systems, and she reported increased seizures.It was noted that the patient has not had any recent falls or trauma to the generator site.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient's generator was replaced.The explanted product has not been received for analysis to date.No other relevant information has been received to date.

Event Description

It was noted that the generator could be interrogated before the replacement surgery and device diagnostics were normal.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11286957
• MDR Text Key: 230544847
• Report Number: 1644487-2021-00190
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 03/29/2021

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: 10/16/2016
• Device Model Number: 106
• Device Lot Number: 203367
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 03/18/2021
• Supplement Dates FDA Received: 03/12/2021; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR