MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Unspecified Infection (1930)

Event Date 08/14/2019

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 by the patient that they went to the emergency room because they were in a lot of pain and a ct was performed which identified an infection around the vns generator.The neurologist at the facility indicated the patient's generator would need to be removed.The device history records were reviewed for the patient's generator and lead and the products were sterilized per labeling prior to distribution and passed all quality and functional specifications.No known relevant surgical intervention has occurred to date.Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8955767
• MDR Text Key: 156298360
• Report Number: 1644487-2019-01711
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2012
• Device Model Number: 102
• Device Lot Number: 2760
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2010
• 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: 52 YR