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 Unspecified Infection (1930)

Event Date 07/19/2018

Event Type  Injury  

Event Description

Patient's generator was explanted due to infection.Surgeon had been managing an infected wound at the generator site for about a week and had decided that patient needed to be explanted and the wound cleaned.After explant, the wound was thoroughly cleaned with several types of antibiotic irrigations, both manual and electrically boosted.Surgeon then decided by to re-implant due to the localized nature of the infection and because the wound could be adequately disinfected at operation minimizing the chance of re-infection.A review of device history records showed that both the lead and generator were sterilized prior to distribution.Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

• 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: 7826605
• MDR Text Key: 118558432
• Report Number: 1644487-2018-01518
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Other
• Type of Report: Initial
• Report Date: 08/29/2018

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: 02/20/2020
• Device Model Number: 106
• Device Lot Number: 5640
• Event Location: Other
• Initial Date Manufacturer Received: 08/05/2018
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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: 10 YR