MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 10/20/2016

Event Type  malfunction  

Event Description

It was reported by a physician¿s office that they were having difficulty interrogating a patient¿s device.It was believed the battery in the programming wand may possibly be dead because they were unable to interrogate the patient¿s device and received an error message indicating "no connectivity", however the cause of the failure to program was unknown as they did not have a 9 volt battery available at the time.Additional relevant information has not been received to-date.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 6105073
• MDR Text Key: 60428381
• Report Number: 1644487-2016-02646
• 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
• Report Date: 10/20/2016

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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