MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Difficult to Interrogate (1331)

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

Event Date 10/31/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that a physician¿s office was having issues interrogating a patient¿s device.It was stated that this patient¿s device had not been interrogated since (b)(6) of 2015.The battery status back then was indicated as ¿green.¿ the patient was implanted in 2011 so it indicated by the nurse that it was possible that the battery was dead.However a battery life calculation was performed and results showed over 10 years remaining.Troubleshooting was performed by pressing the two red buttons on the back of wand and confirming the light came on and stayed on about 25 seconds.She confirmed the tablet was not plugged into the wall.She unplugged and re-attached the cable, waited 15 seconds and then plugged it back in and tried re-interrogating.She tried interrogating and still wasn¿t able to interrogate the device.It was stated that the patient¿s generator was a bit hard to get to because it was deep into the breast area so she attempted to push a bit harder but still was not able to communicate.There are no suspected issues with the programming system as troubleshooting was performed with the system on a demo and the demo device was successfully interrogated.The patient has not been back to the physician¿s office to re-interrogate the device.No additional information has been confirmed to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6122966
• MDR Text Key: 61019333
• Report Number: 1644487-2016-02718
• 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: 10/31/2016

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
• Device Expiration Date: 05/18/2013
• Device Model Number: 103
• Device Lot Number: 3033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2011
• 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: 17 YR