MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Device Inoperable (1663)

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

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that the explanting facility will not returned explanted devices without patient consent; therefore, device analysis cannot not be performed.

Event Description

An implant card was received indicating that the vns patient¿s generator was replaced due to neos = yes.Additional programming and diagnostic history was received showing normal diagnostic results through (b)(4) 2013.

Event Description

Follow-up with the surgeon was performed, and he reported that electrocautery was not used during the repositioning surgery on (b)(6) 2013 or during any other procedures between implant in (b)(6) 2014.It is known and addressed in device labeling that exposure of electrocautery or rf device can damage the generator and cause premature depletion.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description

It was reported that the vns patient's generator showed ifi - yes.The physician reported that the generator must be faulty as it was implanted in (b)(6) 2013.It was reported that the patient underwent another surgery in (b)(6) 2013.It was reported that device diagnostics were within normal limits.The patient was referred for generator replacement.The patient underwent generator replacement on (b)(6) 2014.The generator is expected to be returned for analysis, but has not been received to date.Attempts to obtain additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 3734824
• MDR Text Key: 4499155
• Report Number: 1644487-2014-00940
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2014

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: 06/30/2014
• Device Model Number: 105
• Device Lot Number: 3439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2014; 06/18/2014; 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• 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: 70 YR