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

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During patient's first follow up appointment after vns implant surgery on (b)(6) 2015, bruising was observed around the generator incision site.No physical trauma is suspected to have occurred to the site.Patient was sent for labs and was referred to a surgeon for second opinion.The patient's bruising was reported to be abnormal and the cause was unclear.It was also reported that the patient had a (b)(6) infection prior to this implant surgery in the chest area and so the patient was referred for a second consult.On (b)(6) 2015, swelling was observed near the incision site but there was no redness or warmth.No interventions were taken and patient was asked to follow up in a few weeks.Additional information was received that the patient has a seroma around the generator pocket, pain in the chest and some significant bruising.Patient is to undergo a generator pocket revision surgery but no known surgical interventions has occurred to date.

Event Description

A pocket revision was planned for the seroma but patient underwent full explant on (b)(6) 2015 due to infection on the generator side.Patient was given antibiotics and neurologist was informed to increase medications.The explanted devices are expected to be returned but have not been received.A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Event Description

The generator and lead were received on 12/01/2015.Analysis is underway but has not been completed.

Manufacturer Narrative

Describe event or problem, corrected data: analysis of the generator was completed on 12/22/2015.Previous supplemental mdr #2 was submitted prior to the completion of the generator analysis on 12/22/2015.

Event Description

Analysis was completed for the generator and lead.In the (b)(4) lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.Furthermore, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.002 volts, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The outer silicone tubing has an abraded opening.Other than the above mentioned observation and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• 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: 5092193
• MDR Text Key: 26355336
• Report Number: 1644487-2015-05846
• 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: Other Health Care Professional
• Type of Report: Followup,Followup,Followup
• Report Date: 08/28/2015

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: 01/22/2017
• Device Model Number: 105
• Device Lot Number: 4245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2015; 12/22/2015; 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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: 54 YR