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

Model Number 102

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

Patient Problems Dyspnea (1816); Edema (1820); Pain (1994); No Code Available (3191)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported via clinic notes received that the patient was having on and off swelling around the vns site as well as pressure.The patient felt that the vns had shifted or moved and found it hard to lift anything.It was revealed that the patient was looking to have the vns explanted as, additionally, a few years prior, the patient had the vns disabled as it seemed to worsen her shortness of breath, due to the vns sitting over the top of the lung that tended to develop pneumonia.The vns was disabled and the patient expressed relief and stated that she could draw a full breath.The patient also reported that she had not noted any real benefit with the vns.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The patient's device was explanted.The explanting facility discards product, so no analysis could be performed.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: 7003137
• MDR Text Key: 91090162
• Report Number: 1644487-2017-04730
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

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: 02/29/2008
• Device Model Number: 102
• Device Lot Number: 015484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 05/01/2018
• Supplement Dates FDA Received: 11/06/2017; 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2006
• 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: 50 YR