MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Wound Dehiscence (1154); Fever (1858); Inflammation (1932)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

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 that the patient underwent vns implantation and after the mother reported the patient presented with edema and dehiscence at the wound site and also has a fever for which she went to the emergency room and was hospitalized.The surgeon was contacted and per the surgeon, he believes the case is associated with lack of post-operative care of the wound at home due to poor sanitary practices at home and associated with episodes of aggressiveness of the patient, which leads to excessive manipulation of the wound.It was noted that the symptoms reported were not caused by the device but rather due to an oversight in personal care of the patient.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 11844080
• MDR Text Key: 251280858
• Report Number: 1644487-2021-00680
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/18/2021

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: 08/07/2021
• Device Model Number: 103
• Device Lot Number: 205031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2019
• 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; Other; Required Intervention
• Patient Age: 6 YR