MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Impaired Healing (2378)

Event Date 10/07/2019

Event Type  Injury  

Event Description

It was reported by the patient that they are able to feel their device and feel it turning when lifting the left arm.Per the patient, the surgeon informed her that as people age their skin gets thinner and did not see anything wrong with her device.The patient also reported that the wound took some time to heal this time.Response was received from the physician's office noting that the cause of the migration is most likely a combination of manipulation but mostly patient physiology.The intervention planned is for plastic surgeon to evaluate the patient and see if possible stabilization can be performed; however no known intervention is known to have occurred to date.Non-absorbable sutures were confirmed to have been used to secure generator in place but further follow-up was needed on this.It was stated that the patient's wound itself has healed but the impaired wound healing may be due to internal scar tissue reconfiguring post-operatively.It was stated that the thinning of the skin is not due to vns and the patient's tissue may not be as robust at this point.No surgical intervention for the migration has been reported to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9811363
• MDR Text Key: 258029823
• Report Number: 1644487-2020-00416
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2021
• Device Model Number: 106
• Device Lot Number: 204869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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: 61 YR