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 No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A report was received indicating that following pocket closure during a device implant an end of service message was observed.Diagnostics performed prior to pocket closure revealed normal battery status and normal lead impedance.It was stated that electrocautery was not used between the first and second diagnostic measurements.The device was then successfully explanted and replaced with no issues.Manufacturing records were reviewed for the device and no unresolved nonconformances were identified prior to device distribution.Data from the programmer used at implant has been obtained and is currently under review.The explanted device has been returned to the manufacturer and is currently undergoing product analysis.

Event Description

Data obtained and decoded from the user's programming system confirmed that an end of service indicator had been observed following normal readings.An end-of-service warning message was verified during testing and was 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 was likely exposed to an electro-cautery tool during device implant/explant.A reset of the pulsedisabled bit in the pulse generator memory was performed to allow for an output to once again be provided by the pulse generator for subsequent testing.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.066 volts as measured during testing shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 3.082% of the battery had been consumed.Other than the noted event (pulsedisabled), there were no additional performance or any other type of adverse conditions found with the pulse 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: 5697599
• MDR Text Key: 47791553
• Report Number: 1644487-2016-01223
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2017
• Device Model Number: 103
• Device Lot Number: 203332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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 Age: 23 YR