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 Tissue Breakdown (2681)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as extrusion is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had their generator explanted due to extrusion.The generator was explanted to preclude a serious injury and to prevent an infection, as the generator was physically visible through the skin.A medical professional indicated that the patient did lose a lot of weight and then gained the weight back prior to the extrusion.The device history records were reviewed and indicated that the generator and lead were sterilized according to specifications and passed functional specifications prior to distribution.Device evaluation not necessary as extrusion is not related to the functionality or delivery of therapy of the device.No further 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8131284
• MDR Text Key: 129294191
• Report Number: 1644487-2018-02208
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

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: 06/08/2019
• Device Model Number: 106
• Device Lot Number: 204169
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2017
• 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: 45 YR