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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 07/11/2015

Event Type  Injury  

Manufacturer Narrative

Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.

Event Description

Adverse event form received on (b)(6) 2015 reported that this patient had an occurrence of post-op infection causing pain and swelling at the site.On (b)(6) 2015 the patient presented with a complaint of pain at the surgery site with two episodes of fever for the past 3 days.Upon examination, mild infection at the surgery site was found.Patient was started with oral antibiotics for the infection.The outcome of the event is that it is recovering and the seriousness was considered based on initial hospitalization and intervention required to prevent a serious outcome (medication).The infection is a post-op infection that occurred less than 1 week after implantation.No additional relevant information has been received to date.

Event Description

Updates on 03/10/2016 states that the outcome of the infection is recovered with sequelae on (b)(6) 2015.He was provided with oral antibiotics and later switched to iv antibiotics.

Manufacturer Narrative

Initial mdr and follow-up report #1 inadvertently omitted information about the location of the infection.

Event Description

The infection was present at the site of the chest (site of the pulse generator) and the neck (site of electrode).

• 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: 5000931
• MDR Text Key: 22879267
• Report Number: 1644487-2015-05487
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Followup,Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 103
• Device Lot Number: 202820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• 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: 43 YR