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

Model Number 102

Device Problem Low Battery (2584)

Patient Problems Weight Changes (2607); No Code Available (3191)

Event Date 05/23/2017

Event Type  Injury  

Event Description

Report received that a patient was referred for a generator replacement.It was thought that the battery had depleted since the patient could no longer feel stimulation and the generator could not be interrogated.Over the three months after the battery had likely depleted, the patient gained 20 pounds due to an increased appetite.It was also reported that the patient had a decrease in the quality of her sleep which the patient admitted might be related to anxiety over her generator battery depleting.The patient's generator was later replaced and the reason for replacement was listed as battery depletion on the implant card.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).Describe event or problem, corrected data: initial mdr inadvertently did not include verbiage regarding the available programming history.There was no available programming history for review so the patient's generator history could not be evaluated.

Event Description

Further information was received that before the replacement, the company representative was unable to interrogate the device due to battery depletion.The generator was also reportedly discarded after replacement.Further information was received from the patient's neurologist that there was no known preexisting relationship between vns and appetite and weight changes but that there was a possibility vns stimulation helped control these issues.It was also said that the programmer used during the initial failure to program had worked since that event.There was no available programming history data for this patient's generator so the expected battery life and patient settings could not be evaluated.The battery had likely reached a status of intermittent and weakened stimulation until it had completely depleted which caused a lack of therapy during the months preceding the complete depletion.This change in therapy contributed to the weight gain and appetite changes.No further 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: 7051028
• MDR Text Key: 92714317
• Report Number: 1644487-2017-04852
• 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
• Report Date: 12/15/2017

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: 05/31/2010
• Device Model Number: 102
• Device Lot Number: 200807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2008
• 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: 48 YR