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

Model Number 103

Device Problems Failure to Interrogate (1332); Battery Problem (2885)

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

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion.The patient¿s generator could not be interrogated during the procedure prior to replacement.The programming system is not expected to have caused or contributed to the event as it has successfully interrogated with other generators following the replacement surgery.A battery life calculation using the available programming history and prediction tables showed approximately 4.8 years from beginning of life to end of service.The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the generator was completed on 10/28/2014.The pulse generator was placed at a distance of one-inch (spacer block) from the programming wand and interrogated at multiple orientations adjacent to the programming wand.The pulse generator interrogated at all orientations.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi condition.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• 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: 3761647
• MDR Text Key: 4487080
• Report Number: 1644487-2014-01065
• 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: 03/26/2014

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: 10/31/2011
• Device Model Number: 103
• Device Lot Number: 2550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2010
• 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: 54 YR