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

Model Number 103

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was reported that while attempting interrogation on a vns patient's generator the handheld showed a "check sum" error and showed the generator at 50% battery life.It was reported that the patient's generator had been recently implanted.Another handheld was utilized and the interrogation was successful and no longer showed 50% battery life.A new programming tablet was requested and the handheld was returned for analysis.Analysis is underway, but has not been completed to date.

Event Description

The programming history decoder identified that the interrogation performed on (b)(6) 2014 identified no problems with the device.The lead impedance was within normal limits (2465 ohms).No anomalies were identified.

Manufacturer Narrative

Corrected data: initial and follow-up mfr.Report inadvertently reported on the incorrect suspect device.

Event Description

Analysis of the handheld was completed on (b)(6) 2014.No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.Analysis of the flashcard was completed on (b)(6) 2014.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.Programming history from the handheld showed that device interrogation on 06/18/2014 showed the battery status as ok.

Manufacturer Narrative

New information corrects the date of event.This was inadvertently left off of follow-up mfr.Report #01.

• 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: 3938452
• MDR Text Key: 4571910
• Report Number: 1644487-2014-01800
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 103
• Device Lot Number: 202430
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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: 5 YR