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 Foreign Body Reaction (1868); Post Operative Wound Infection (2446)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient developed a post-operative infection following implant of the most recent previous generator.The infection cleared up after antibiotics.At the patient's later generator replacement, a foreign body (surgical sponge left from the implant surgery) was found near the generator location; however, it was determined that there was no sign of infection related to the foreign body.Device history record was reviewed for the suspect generator.The device was sterilized and passed all quality control measures prior to distribution, and no unresolved nonconformances were found prior to distribution.X-ray image of the generator and the foreign body from prior to generator replacement surgery was reviewed, and the presence of the foreign body was confirmed.No anomalies with the vns were noted.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

• 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: 12865730
• MDR Text Key: 281209411
• Report Number: 1644487-2021-01641
• 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: 11/23/2021

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: 03/25/2021
• Device Model Number: 1000
• Device Lot Number: 204855
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2019
• 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): Other
• Patient Age: 30 YR
• Patient Sex: Male