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 Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 11/06/2016

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

Report received that a patient's generator and lead were explanted due to an infection.This occurred about 14 months after the initial implant.Further information was provided from the explanting surgeon that, at the time of the explant, the patient presented with wound dehiscence and an open pocket.The generator was reportedly seen coming out of this open wound with pus.There was reportedly no note of the patient picking at the generator.A review of the generator's device history record indicated it had been properly sterilized prior to release for distribution.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: 7304683
• MDR Text Key: 101231696
• Report Number: 1644487-2018-00303
• 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: Physician
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2017
• Device Model Number: 106
• Device Lot Number: 203490
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2015
• 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: 11 YR