MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Local Reaction (2035)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient developed granulation tissue hyperplasia following vns implant and had to be hospitalized and have an additional surgery.The generator had to be replaced during this surgery as it could not be communicated with, reported in mfr.Report # 1644487-2021-01480.It was noted that the physician thinks the cause of the granulation tissue hyperplasia could be due to patient physiology as the patient is confirmed as allergic physique.It is noted that patients can be allergic to certain ingredients contained in the product, or poor postoperative healing can lead to redness and swelling the wound site, which may not necessarily be allergic.The device history records of the generator were reviewed.The generator passed final quality and functional specifications prior to release and was confirmed to be hp sterilized.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12689642
• MDR Text Key: 278147321
• Report Number: 1644487-2021-01481
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 22 YR