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

Model Number 106

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that high impedance was registered on the patient's vns system.The site performed a chest x-rays and reported to not show a visual anomaly with the lead.The device was disabled at that time and the patient was referred for surgery.The generator and lead dhrs were reviewed and found that all specifications met prior to distribution.The patient underwent surgery on (b)(6) 2016.At the start of the case, system diagnostics were performed that still showed high impedance.During the case, the test resistor was inserted into the generator, and a generator diagnostic showed expected values that were within normal limits.The lead was re-inserted and the impedance was measured to be within normal limits, 3718 ohms on one test and 3659 ohms on the second.The surgery was completed without replacing any products.The x-ray images taken prior to the case were reviewed by a company field representative, and the lead could not be visualized to be inserted past the generator connector block in the images.No additional pertinent 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: 5906415
• MDR Text Key: 54057430
• Report Number: 1644487-2016-01927
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: 106
• Device Lot Number: 4593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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 Age: 17 YR