MAUDE Adverse Event Report: LIVANOVA USA, INC. CYBERONICS TUNNELER MODEL 402; INSTRUMENT, SURGICAL, NON-POWERED

Model Number	402
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Vns tunneler used from left neck to left chest, surgeon attempted to remove the tip to pass lead but unable to screw off.Ultimately, needed to get a new tunneler.Surgeon able to use track made by other tunneler.Manufacturer response for instrument, surgical, non-powered, cyberonics® tunneler model 402 (per site reporter).Following up.

• Brand Name: CYBERONICS TUNNELER MODEL 402
• Common Device Name: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11372024
• Report Number: 11372024
• Device Sequence Number: 3803476
• Product Code: HAO
• UDI-Device Identifier: 05425025750238
• UDI-Public: (01)05425025750238
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/01/2021
• Report Date (Section F): 02/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: 402
• Device Lot Number: 5393532
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 32
• Date Report Sent to FDA: 02/01/2021