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

Model Number 103

Device Problems Electromagnetic Interference (1194); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool.

Event Description

It was reported that the vns patient underwent non-vns related spinal surgery in which electrocautery was used.Following this procedure, the patient¿s device was reported to be pulse disabled.Post-operative diagnostic results showed an end of service condition.The patient underwent generator replacement surgery on (b)(6) 2014.The explanted generator was returned to the manufacturer for analysis.Review of the as-received decoder showed that the generator was not pulse disabled and not at end of service with the battery measured at 2.762v.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.Attempts for additional relevant information have been unsuccessful to date.

• 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: 4268901
• MDR Text Key: 5166252
• Report Number: 1644487-2014-03090
• 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: 10/23/2014

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: 05/31/2013
• Device Model Number: 103
• Device Lot Number: 3031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2011
• 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: 56 YR