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

Model Number 103

Device Problems Low Battery (2584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was reported that the patient¿s caregiver believed the patient¿s vns was no longer working.The patient had reportedly experienced self-injurious behaviors, which the caregiver interpreted as a sign the patient¿s generator was no longer delivering therapy.No additional pertinent information has been received to date.

Event Description

Follow up with the office of the treating physician showed that the patient¿s self-injurious behaviors were representative of her historic depression symptoms.The physician believed that the vns generator was at end of life supported by a vns battery status indicator.No additional pertinent information has been received to date.

Event Description

It was reported that the patient¿s generator replacement surgery was completed.The explanted generator was received by the manufacturer and is undergoing product analysis.No additional pertinent information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned generator.Visual examination showed only observations consistent with the explant process, including evidence of use of electrocautery through burn marks.No surface abnormalities were noted on this device.With the generator opened, no visual anomalies were found on the printed circuit board assembly.During the bench interrogation, the pulse-disabled and end of service (eos) warnings were set.The pulse-disabled status would not reset.The printed circuit board assembly was subjected to a postburn electrical test.All tests required for proper device function passed.The battery measured 1.803 volts, confirming an eos condition.Although it is possible the generator was previously at an neos condition before being hit with electrocautery, the ultimate cause of the eos condition was determined to be normal current consumption.The internal device data showed that 114.370% of the expected battery capacity had been consumed.Review of the internal device revealed no anomalies.Other than the expected eos condition, there were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 6347990
• MDR Text Key: 67923724
• Report Number: 1644487-2017-03243
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2017

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: 11/30/2013
• Device Model Number: 103
• Device Lot Number: 201956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/27/2017; 05/19/2017; 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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: 38 YR