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

Model Number 103

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to near end of service.Clinic notes were received indicating that the patient¿s device battery indicator showed 100% battery life remaining during an office visit on (b)(6) 2015; however, during an office visit on (b)(6) 2015, the battery life indicator showed 20% battery life remaining.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received from the neurologist stating that the patient did not have any surgeries since implant during which the generator may have been struck by electro-cautery.However, the neurologist did state that the patient swipes her vns magnet excessively which he believes may have contributed to the premature battery depletion.Additional information was received that the patient's device was showing ifi=yes during a follow up appointment (b)(6) 2015.The patient then underwent a generator replacement surgery on (b)(6) 2015 due to neos=yes.The explanting facility discarded the explanted device; therefore, no analysis can be performed.Programming data was received.Review of the received programming data revealed that upon the initial follow up appointment following the patient's (b)(6) 2014 generator replacement surgery, the generator was seen to be pulse disabled with a pulse disabled error message being seen.The eos pulse disabled condition found upon the first follow-up visit after implant surgery suggests that the device was likely hit with electro-cautery during device implant.This would account for the decreased in generator longevity.Based on the data received, the patient's recorded magnet swipes did not appear to be excessive.

Manufacturer Narrative

Manufacturer Narrative

Review of the available programming and diagnostic history was performed.

• 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: 4622778
• MDR Text Key: 5655469
• Report Number: 1644487-2015-04195
• 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
• Report Date: 02/25/2015

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: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 103
• Device Lot Number: 202360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• 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: 24 YR