MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 01/30/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported that the patient¿s vns was being explanted due to discomfort at the generator site and that the vns has been disabled for 2 years.The patient underwent explant of the device and good faith attempts for the return of the explanted product has not been successful to date.It was previously reported on (b)(6) 2013 that the patient was experiencing pain along the lead site upon stimulation and had been going on at all levels of stimulation (0.25ma and higher).The patient¿s device was interrogate and turned off.It was then reported on (b)(6) 2013 that the patient complained of pain along the whole lead and generator site, and it came and went with stimulation cycles.The patient has always felt the pain since implantation on (b)(6) 2013.The patient was seen by the physician on (b)(6) 2013 gain and the device was turned back on to output=0.25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0.25ma/magnet pulse width=250usec/magnet on time=60sec.The patient immediately complained of discomfort along the lead path.Normal mode diagnostics were then performed which showed a dcdc of 0.Then system diagnostics were performed which showed a dcdc of 3.The patient stated that he had discomfort along the lead the entire time and that it subsided once the generator was turned off.It was noted that the patient has had his generator up to output=1.25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1.5ma/magnet pulse width=250usec/magnet on time=60sec which is when he was subsequently turned down due to discomfort.The patient was referred for x-rays and noted that if a lead break is observed then he would like the device removed, but if there is no lead break then he wants the device explanted.X-rays were received on (b)(6) 2013.The generator is visible in the left chest and is normally placed.The lead pin appears fully inserted inside the connector block.Feed thru wires appear intact.Lead wires at the connector pin appear intact.Lead is present behind the generator.The lead is visible routing upwards to the left neck.The electrodes appear aligned.A strain relief bend is present and is placed per labeling.One tie-down is present and is securing the bend.The presence of a strain relief loop cannot be assessed due to poor image quality.There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead.Based on the images available, a cause for the painful stimulation cannot be established.Note that an anomaly in the lead portion not visible cannot be ruled out.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).

Event Description

The explanted lead and generator were received by the manufacturer.Lead product analysis was completed.A section of the lead was returned for analysis with the lead connector still attached to the generator.A continuity check was performed between the set-screw and the end of the lead portion while attached to the generator.Proper contact between the set-screw and the lead pin was present.No discontinuities were identified within the returned lead portion.Set-screw marks were identified on the connector pin, indicating that proper contact between the set-screw and the connector pin was present at one point.Due to a portion of the lead not being returned for analysis, an evaluation cannot be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.Generator product analysis was completed.The device output signal was monitored for more than 24 hours with the generator placed in a simulated body temperature environment.There was no signs of variation in the generator's output signal and the device provided the expected level of current.The generator communicated as received and no eri flag was set.The diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.There was no abnormal performance or other adverse conditions found with the generator.

• Brand Name: PULSE GEN MODEL 102
• 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: 4242424
• MDR Text Key: 5013342
• Report Number: 1644487-2014-02984
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2014
• Device Model Number: 102
• Device Lot Number: 202017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2012
• 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): Other
• Patient Age: 28 YR