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

Model Number 103

Device Problem Failure to Interrogate (1332)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

It was reported that the psychiatrist was unable to interrogate the patient's generator.Troubleshooting was attempted with the wand.The wand battery light was checked and was on for 25 seconds.Repositioning of the wand was attempted but did not yield successful interrogation.The device was unplugged from the wall outlet, but the interrogation was still unsuccessful.No data received light could be seen over generator or over a computer screen.Patient interrogation has worked in this area before so electromagnetic interference was not suspected.As generator interrogation was unsuccessful despite the troubleshooting, a replacement wand was sent to the physician to rule out a wand issue.Further follow up showed that the physician received the new wand and that the patient was scheduled for a visit.Attempts for additional information were unsuccessful to date.

Manufacturer Narrative

Event Description

The physician's old wand was returned for analysis.No visual or mechanical anomaly was identified.Continuity testing of the serial data cable and the battery cable passed.No issues on the wand were found that would have contributed to the failure to interrogate patient's generator.Additional information was received that the patient's generator was successfully interrogated with the new wand.The patient's settings are 1.25ma/30hz/500usec/30sec on/5 minutes off.Patient was also able to perceive stimulation from the vns generator during the appointment.

• 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: 4806344
• MDR Text Key: 5918086
• Report Number: 1644487-2015-04808
• Device Sequence Number: 1
• Product Code: MUZ
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2014
• Device Model Number: 103
• Device Lot Number: 202148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2012
• 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: 61 YR