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); Seizures (2063)

Event Date 04/17/2017

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

It was reported that a patient developed an infection after a recent generator replacement surgery.The location of the infection was unknown.The patient was hospitalized in the er due to the infection.The patient then experienced status epilepticus due to the infection, so the physician programmed the patient's vns on in response.The nurse did not provide further information about the patient's infection.She reported that the patient had been admitted to the er twice after experiencing status epilepticus, according to her notes.The patient's vns was turned on during the first hospital admission.The patient notably had a fever during the second admission, indicating a possible infection.The patient's status epilepticus resolved after the vns was programmed on in the hospital.Device history records for the generator revealed that the device met all specifications for sterility prior to distribution.No additional 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: 6695427
• MDR Text Key: 79347028
• Report Number: 1644487-2017-04116
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

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: Health Professional
• Device Expiration Date: 11/08/2018
• Device Model Number: 106
• Device Lot Number: 5137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2017
• 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): Hospitalization
• Patient Age: 30 YR