MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Seroma (2069)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

Patient underwent a generator replacement and while in surgery, the surgeon noticed a large amount of pink purulent fluid that was able to be expressed out.A sample of the fluid was sent to the lab for testing and there wasn't any growth, no infection, on the sample.Design history record review for the generator performed.The generator was confirmed to have been sterilized prior to distribution into the field.The device passed all specifications.No other relevant information has been received to date.

Manufacturer Narrative

B5 describe event or problem , corrected data: initial report inadvertently left out patient being placed on antibiotics.

Event Description

After the replacement surgery for this patient, they were placed on a broad spectrum antibiotic for precaution due to the pink purulent fluid found in the generator pocket.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11108810
• MDR Text Key: 224794198
• Report Number: 1644487-2021-00002
• 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
• Report Date: 02/02/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2014
• Device Model Number: 105
• Device Lot Number: 3353
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR