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

Model Number 105

Device Problems Thermal Decomposition of Device (1071); Failure to Interrogate (1332)

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

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The generator was near end of service but was unable to be interrogated at the time of the procedure believed to be due to end of service.The lead was replaced prophylactically.During the procedure, the surgeon replaced the patient's generator and subsequently used electrocautery to replace the lead.When the device was tested after the device replacements, the replacement generator showed an end of service condition.The device was tested prior to the use of electrocautery and the device showed battery status as ok.Another generator was used to complete the procedure.The explanted devices and the opened but unused generator were returned to the manufacturer for analysis.The end of service condition and failure to program with the explanted generator was the result of normal, expected battery depletion.The device performed according to functional specifications.Analysis concluded that no abnormal performance or any other type of adverse condition was found.Review of the data from the opened but unused generator indicated that the pulse disabled byte was set to a value that represents a vbat

Manufacturer Narrative

(b)(4).

Event Description

Analysis of the returned lead portion was completed.The condition of the returned lead portion were consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.

• 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: 4905425
• MDR Text Key: 6069907
• Report Number: 1644487-2015-05137
• 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: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: 105
• Device Lot Number: 4200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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: 31 YR