MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 03/19/2019

Event Type  Injury  

Event Description

It was reported that the patient was referred for surgery due to the surgeon¿s concern that the lead pin may have slipped out and the physician has reportedly obtained x-rays.Clinical notes were later received which reported that high impedance of >10,000 ohms was seen on the patient¿s vns and that the patient was experiencing an increase in seizures.The patient's generator was later replaced and lead impedance was within normal limits.The explanted generator was discarded.Information was later received that the surgeon had visually confirmed that the lead pin was not inserted past the second connector block both intra-operatively and upon review of the x-rays.The surgeon chose to replace the generator instead of re-inserting the pin into the generator.Additionally, there were no abnormalities were seen both visually (in the or) and on the x-rays.No additional or 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8511132
• MDR Text Key: 141818227
• Report Number: 1644487-2019-00717
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2020
• Device Model Number: 106
• Device Lot Number: 204641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2018
• 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: 32 YR