MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

It was reported the patient's vns was programmed off due to high impedance.The patient was scheduled for a full revision.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The patient underwent a vns generator replacement due to the reported high impedance.The device was tested in pre-op and still showed high impedance.The physician noted the old generator "felt loose" during the explant.When the new generator was implanted on the same lead, the impedance was within normal limits.It was noted the surgeon attempted to re-insert the lead pin into the original generator, but he still received high impedance.The device is not expected to re returned for analysis as the explanting facility is a no return site.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The date the patient's vns device was evaluated and programmed off was clarified by the physician's nurse.She also stated that the patient's husband had called about it the day before as she was having some painful stimulation.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6533121
• MDR Text Key: 74047369
• Report Number: 1644487-2017-03701
• 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,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2017
• Device Model Number: 106
• Device Lot Number: 203655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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: 74 YR