MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

A physician initially reported that a vns patient may have a seroma or infection.The site of the seroma/infection was not stated.A subsequent call was received from a hospital indicating that the same patient had their vns pulse generator and lead explanted with no replacement.The caller indicated that at the time of the explant procedure the surgeon did not have a torque when to remove the lead from the generator so he cut the lead.The generator still has a small portion of the lead connected and this along with a portion of the lead containing the helical coil electrodes was returned for product analysis.A form received with the devices indicated the reason for explant to be infected implant.The explanted devices are currently undergoing product analysis.The surgeon confirmed that the condition was confirmed to be an infection and that the seroma was part of the infection.The infection was at both the generator and lead area and cultures indicated the infection to be pseudomonas aeruginosa.

Event Description

The surgeon indicated that the cause of the infection was unknown.There were no performance or any other type of adverse condition found with the pulse generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The pulse generator diagnostics were as expected for the programmed parameters.The battery, 2.944 volts as measured during testing shows an ifi=no condition and device memory revealed that 5.223% of the battery had been consumed.No obvious anomalies were noted with the returned lead portions and the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.The majority of the lead assembly (body) including the electrode array section was not returned therefore an evaluation and resulting commentary cannot be made on that portion of the lead.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions revealed no discontinuities.

• Brand Name: PULSE GEN MODEL 106
• 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: 5709139
• MDR Text Key: 46910405
• Report Number: 1644487-2016-01294
• 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: 05/19/2016

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: Health Professional
• Device Expiration Date: 01/27/2018
• Device Model Number: 106
• Device Lot Number: 203712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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: 20 YR