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

Model Number 102

Device Problems Failure to Power Up (1476); Failure to Deliver (2338)

Patient Problem Palpitations (2467)

Event Date 02/11/2016

Event Type  Injury  

Event Description

Information was received which indicated that the patient was experiencing heart palpitations.The patient then had their device programmed off and the programmed back on with no changes in the palpitations on (b)(6) 2016.Later on (b)(6) 2016 when diagnostics were performed, it was noted that the patient's generator was at near end of service.The physician then believed that the generator was delivering stimulation erratically and thus the patient was having these palpitations.The patient's device was then lowered to an output current of 0.5ma on (b)(6) 2016.The patient's device was then programmed off on (b)(6) 2016.With the device disabled, the heart palpitations resolved.The physician's office indicated that the patient's generator had completely depleted as of (b)(6) 2016.An internal battery life calculation was performed using settings for the patient's device that were found in the programming history database.The calculation found that the patient's generator should have 3.8 years remaining until reaching near end of service.However the accuracy of this result may be affected by missing parameter changes and magnet swipes that are not taken into account.No surgical intervention has occurred to date.No other relevant information has been obtained to date.

Manufacturer Narrative

Description of event, corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr.

Event Description

Information was received indicating that the patient had heart palpitations that were self reported.Per clinic notes dated (b)(6) 2016 state that these heart palpitations were not believed to be related to vns therapy and the patient's device was then programmed back on.The patient then reported having tachycardia that was confirmed by an ekg in an er.It was at this point when the physician disabled the device and believed that the erratic stimulation from the depleting battery of the vns was causing the patient's tachycardia.With the device disabled, the tachycardia resolved.The physician's office indicated that the patient's generator had completely depleted as of (b)(6) 2016.No other relevant information has been received to date.

Event Description

The patient underwent replacement surgery where her generator was replaced due to battery depletion.Diagnostics with the lead and new generator were within normal limits.A nurse from the explanting facility stated that the explanted generator was sent to pathology and has not been recovered.Therefore no product return is expected.No other relevant information has been received to date.

• 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: 6090530
• MDR Text Key: 59553471
• Report Number: 1644487-2016-02571
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2007
• Device Model Number: 102
• Device Lot Number: 014097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2016; 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2005
• 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: 54 YR