MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

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

Event Date 07/18/2017

Event Type  Injury  

Event Description

It was reported that the patient was in clinic and presented with an extruding generator.The physician noted that the patient had an infection removed from under his arm about 3 months prior and he suspects this was the cause of the extrusion.The patient¿s full system, generator and lead, was removed and he was placed on antibiotics.At this time, it appears that the infection that the patient had in his underarm spread to the generator site causing infection at the chest incision and the generator to extrude.The physician does not know what caused the infection at the underarm that started the whole issue.The explanted device will not be returned.The design history record for the generator was reviewed and it was confirmed that the device was hp sterilized prior to distribution into the field.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 7011277
• MDR Text Key: 91382622
• Report Number: 1644487-2017-04744
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/08/2017

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: 02/05/2017
• Device Model Number: 105
• Device Lot Number: 4273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• 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: 61 YR