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

Model Number 106

Device Problem High impedance (1291)

Patient Problems Chest Pain (1776); Neck Pain (2433)

Event Date 01/09/2017

Event Type  malfunction  

Event Description

It was reported that during an office visit the generator was interrogated and a high impedance warning presented.The physician had the patient return a week later and upon interrogation the high impedance warning was observed again.The patient complained of painful stimulation in the chest so the physician decided to program the device off and send the patient for x-rays.These x-rays have not been reviewed by the manufacturer to date.A company representative later reviewed the programming data on the physician's tablet.The company representative did not observe any high impedance events however the diagnostic history showed a diagnostic test from a year earlier which were within acceptable limits.No additional relevant information has been received to date.

Event Description

Clarification was received that the patient was experiencing painful stimulation in the neck and not the chest.It was also reported that the patient does not remember any recent trauma that may have contributed to the high impedance however she does have a small child who sometimes bumps her in the neck.Programming data from the physician's tablet and x-rays were received.The programming data confirmed that high impedance had been observed.Review of the x-rays found that the lead's pin appeared to not be fully inserted into the generator.This poor connection between the generator and lead appears to be the likely cause of the high impedance.Manufacturing records of the generator were reviewed and confirmed that the generator passed qc inspection prior to disablement.The patient was scheduled to be evaluated by a surgeon due to the high impedance.However no surgical interventions are known to have occurred to date.

Event Description

It was reported that the patient underwent surgery where the generator was replaced.After the generator replacement the impedance value was within acceptable limits and the lead was not replaced at that time.Historically the explanting facility does not return explanted product to the manufacturer.Therefore product return is not expected.

• 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: 6335425
• MDR Text Key: 67589917
• Report Number: 1644487-2017-03213
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2017
• Device Model Number: 106
• Device Lot Number: 4519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR