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

Model Number 106

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

Patient Problems Local Reaction (2035); No Code Available (3191)

Event Date 12/18/2018

Event Type  Injury  

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 Description

It was reported by the patient that they experienced an allergic reaction following vns surgery and went to the emergency room.The patient indicated that they experienced severe swelling at the chest and neck site as well as difficulty breathing related to their allergic reaction.The physician indicated that the patient had a rash around the surgical sites related to the patient being allergic to the agent used to prepare the surgical site prior to surgery, chlorhexidine prep.The physician indicated that the patient was also allergic to the doxycycline antibiotics consumed.A review of the device history records showed that both the lead and generator were sterilized prior to distribution.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8251305
• MDR Text Key: 133181632
• Report Number: 1644487-2019-00085
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2019

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: 04/20/2020
• Device Model Number: 106
• Device Lot Number: 204466
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR