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 Problem Unspecified Infection (1930)

Event Date 02/04/2019

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 this patient has a wound infection of the left axilla.Additional information was received that the patient first presented with the infection with an aching in their left axilla.The majority of the infection was located at the wound site, but the physician thinks the infection expanded to the generator area, but the wound site was not open.It was stated that this patient has diabetes with poor glycemic control, and therefore is at increased susceptibility to infection.Therefore the physician thinks the bacteria might be penetrated from the wound site at the left axilla and expanded to the generator area.A review of device history records showed that the implanted generator and lead were sterilized prior to distribution.All other quality tests also passed prior to distribution.No known surgical intervention has occurred to date.No further relevant information has been received to date.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.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8424229
• MDR Text Key: 138899917
• Report Number: 1644487-2019-00506
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2018
• Device Model Number: 103
• Device Lot Number: 5126
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2016
• 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: 37 YR