MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Hematoma (1884); Skin Infection (4544)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Patient was referred for a revision due to having a massive hematoma or abscess around their generator.The patient underwent surgery and the surgeon only cleaned the area around the generator pocket, no devices were replaced.The hematoma was assessed to be caused by the patient playing outside and falling in the woods.The surgical intervention was to check the battery infection/hematoma and for both patient comfort and to preclude a serious injury.A device history records (dhr) review was performed and the generator was confirmed to have been hp sterilized prior to distribution into the field.The device passed all specifications, including quality control inspection, and showed no non-conformities, prior to its release into the field for distribution.No other relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

• Brand Name: PULSE GEN MODEL 1000
• 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: 14214158
• MDR Text Key: 290116988
• Report Number: 1644487-2022-00485
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

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: 04/20/2023
• Device Model Number: 1000
• Device Lot Number: 205534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2021
• 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): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male