MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number	106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
Event or Problem Description
Report received that a patient was admitted to the icu due to an infection at the vns surgical site.It was also reported that the patient was having seizures and was put on a ventilator.Further information was received that the infection was not actually at the vns location, but it was not known if it was still related to vns.The manufacturer representative planned to follow-up with the patient in the hospital to check the device.Both the lead and generator were sterilized to specification prior to being released for distribution.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Common Device Name: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7294394
• Report Number: 1644487-2018-00280
• Device Sequence Number: 12121960
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/13/2018
• Device Model Number: 106
• Device Lot Number: 203920
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 20 YR