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

Model Number 103

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

Patient Problem Hyperemia (1904)

Event Date 05/23/2017

Event Type  Injury  

Event Description

A physician stated that during a generator replacement surgery, he identified that a patient had some foreign white substance identified in the generator pocket.Follow-up was performed and the physician's op notes stated that the physician saw something resembling a plastic coating on the fascia under the generator incision site, but that all the scar tissue was normal.The patient was seen post-op and reportedly not experiencing any adverse events related to the surgery and was healing normally.The explanted generator was returned to the manufacturer for analysis which has not been completed to date.No further relevant information has been received to date.

Event Description

The explanted generator had analysis completed where the generator diagnostics were as expected for the programmed parameters.The device passed a comprehensive automated electrical evaluation.The stored data showed normal battery consumption and normal impedance values pre-operatively.There were no performance or any other type of adverse condition identified with the 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: 6647872
• MDR Text Key: 77784200
• Report Number: 1644487-2017-03993
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: 103
• Device Lot Number: 2767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2010
• 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): Other
• Patient Age: 14 YR