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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 03/04/2020

Event Type  Injury  

Event Description

Patient was referred for explant, generator and part of their lead, due to experiencing pain.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent surgery to have their generator and lead explanted.The explanted generator and lead have not been received by product analysis 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: 9898251
• MDR Text Key: 186195810
• Report Number: 1644487-2020-00521
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 08/25/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2007
• Device Model Number: 102
• Device Lot Number: 013177
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR