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

Model Number	102
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient developed granulation tissue hyperplasia following vns implant and had to go in for an additional surgery.This event is reported in mfr.Ref #1644487-2021-01481.It was noted that during resistance testing during the surgery, the stimulator would not connect to the programmer.The generator was connected to a test resistor and it still could not be communicated with.They tried changing the position of the generator, turning off the electrical power supply, turning off the electric coagulation, replacing the power supply of the programmer, used another programmer, etc.After several failed communications, the surgeon opted to implant a new generator.The explanted generator is not available for return per hospital policy.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release.No further relevant information has been received to date.
Event or Problem Description
It was confirmed that the generator was able to be interrogated following implantation and also prior to the surgery on (b)(6) during the surgery on (b)(6) it could not be interrogated at all.During the surgery the following equipment was used: bipolar electric coagulation, monitor device, shadowless lamp, etc.There was no difficulty interrogating the new generator that was opened during the surgery.No further relevant information has been received to date.
Event or Problem Description
It was noted that the suspect generator was discarded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12689848
• Report Number: 1644487-2021-01480
• Device Sequence Number: 17280614
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: 102
• Device Lot Number: 6451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 11/30/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/29/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female