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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery device diagnostics with the new generator and existing lead were within normal limits both inside and outside of the generator pocket and once the incision was closed device diagnostics showed ifi - yes.It was reported that electrocautery was not brought back into the field during incision closure; however, it was on the table near the patient which may have discharged during incision closure.A new generator was then implanted.A device programming decoder showed that the battery voltage changed from 3.354v to 2.022v between 9:04:31 and 10:00:41 on (b)(6) 2015.The generator was received for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the returned generator was completed.An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant or explant.A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing.The battery of the returned generator was measured as 3.095 volts showing an ifi=no condition.The downloaded data revealed that 1.629% of the battery had been consumed.Other than the observed pulse disablement and burn marks, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4532316
• MDR Text Key: 5543776
• Report Number: 1644487-2015-03923
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: 103
• Device Lot Number: 203031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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 Age: 13 YR