MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problem Failure to Interrogate (1332)

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

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that the patient's vns generator is not near end of service.Further follow-up showed that the issue was not related to the generator but was due to the depleted 9v battery on the wand.

Manufacturer Narrative

Implant date: if implanted, give date (mo/day/yr); suspect device changed from generator to wand.

Event Description

It was reported on (b)(6) 2015 that the patient¿s neurologist could not interrogate the patient¿s model 103 device.The patient was implanted with this generator in 2012.Programming history was reviewed for this patient and the data was observed from the patient's date of implant on (b)(6) 2012 and no meaningful programming history data is present.No therapy level settings are available to perform a theoretical battery life calculation.No relevant additional information has been obtained to date.

Manufacturer Narrative

• Brand Name: PROGRAMMING WAND
• Type of Device: PROGRAMMING WAND
• 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: 4789289
• MDR Text Key: 5872000
• Report Number: 1644487-2015-04762
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

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: 04/02/2014
• Device Model Number: 201
• Device Lot Number: 3324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: 18 YR