MAUDE Adverse Event Report: CYBERONICS - HOUSTON SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was reported to have had an open wound that was assessed as definitely related to the implant procedure.The event has recovered/resolved.Device history record was reviewed for both the generator and lead.Both devices were sterilized prior to distribution, and no unresolved nonconformances were found.Product return and device evaluation is not necessary as the reported wound dehiscence is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• 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: 13685796
• MDR Text Key: 286850789
• Report Number: 1644487-2022-00230
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2022

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: 01/28/2022
• Device Model Number: 8103
• Device Lot Number: 205219
• Event Location: Other
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2020
• 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: 53 YR
• Patient Sex: Female