MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Information (3190); No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Event Description

During a call to retrieve a battery life calculation estimate, it was reported that the patient would be undergoing a repositioning surgery for an unspecified reason.A separate email indicated that they wanted to do a battery replacement for the patient.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as the reported repositioning surgery is not causing generator replacement.

Event Description

It was reported by the company representative that the patient did not want generator replacement during the repositioning surgery; they just wanted information about battery life no known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient's reason for surgery was that her device had moved due to weight loss.Follow-up with the surgeon's office indicated that the patient's migration was causing her pain.The office indicated that the surgery was for patient comfort.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient's pain was at the generator site.The patient underwent generator repositioning due to comfort.

• Brand Name: PULSE GEN MODEL 105
• 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: 6250662
• MDR Text Key: 64883259
• Report Number: 1644487-2017-03010
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2017

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: 12/23/2015
• Device Model Number: 105
• Device Lot Number: 202810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 03/31/2017; 04/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2014
• 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: 31 YR