MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Additional information was received stating that vns patient¿s device showed the pulse disablement message prior to the mri.The patient¿s device was programmed on back to her previous device settings after the mri.Attempts for additional relevant information, including a copy of the software flashcard, have been unsuccessful to date.

Manufacturer Narrative

Describe event or problem, corrected data: additional information indicates that the warning message appeared prior to the mri.

Manufacturer Narrative

Corrected data (conclusion code): the supplemental 02 report inadvertently included the incorrect conclusions coding.The conclusion coding has been updated to no conclusion can be drawn.

Event Description

It was reported that the patient underwent generator replacement due to eos - yes.The explanted generator was received for analysis.The returned product form indicated that the generator was replaced due to neos - yes.The implant card was received also indicating that the generator was replaced due to battery depletion, near eos/ neos - yes.Analysis is underway, but has not been completed to date.

Event Description

A copy of the software flashcard was obtained.Programming and diagnostic history from the date of the mri was reviewed.Prior to the mri, the device was interrogated, disabled, and interrogated again.Following the mri, the device was interrogated and programmed back on.System diagnostic results performed on that day revealed normal device function.Review of the decoder data confirmed that the generator was disabled due to vbat < eos threshold upon initial interrogation on the date of the mri.Review of the battery voltage from this date revealed 3.065v from the last 24hr voltage measurement.

Manufacturer Narrative

Review of decoder data and programming and diagnostic history.

Event Description

It was reported that the vns patient¿s device was programmed off prior to having an mri.The nurse stated that when the device was programmed back on after mri, the handheld device displayed a warning message indicating ¿pulse disablement with vbat < eos threshold¿.After proceeding through the warning message, the battery icon was fully green and diagnostic testing performed revealed that the eos status was no and the lead impedance within normal limits (impedance value ¿ 2191 ohms).No adverse events were reported.No known interventions have occurred to date.Attempts to obtain additional information are in progress.

Event Description

Analysis of the generator was completed on 07/16/2015.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications the battery shows an ifi=yes condition.In the pa lab there were no performance or any other type of adverse conditions found with the pulse generator.The generator decoder identified that the generator was at a near end of service.

• Brand Name: PULSE GEN MODEL 103
• 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: 3782239
• MDR Text Key: 4671642
• Report Number: 1644487-2014-01135
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Model Number: 103
• Device Lot Number: 201604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2010
• 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: 13 YR