MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)

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

Event Date 12/15/2020

Event Type  malfunction  

Event Description

The patient was initially referred for prophylactic generator replacement.Later notes were received indicating that there was a device malfunction, and the patient is now referred for possible lead revision as well.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Manufacturer Narrative

B6.Adverse event problem codes, corrected data: supplemental report #01 inadvertently did not include the code for "device not returned" in the "type of investigation" codes.

Event Description

Additional information was received indicating that the malfunction that physician to prepare for a possible lead revision was a failure to program.The patient underwent generator replacement surgery and the leads were not replaced.Impedance following the surgery was within normal limits.The explanted generator (suspect device) has not been received by the manufacturer to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11181422
• MDR Text Key: 227752990
• Report Number: 1644487-2021-00077
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2014
• Device Model Number: 102
• Device Lot Number: 3377
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/18/2021; 03/02/2021
• Supplement Dates FDA Received: 02/05/2021; 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR