MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Depression (2361)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

It was reported that a vns patient was feeling an increase in depression due to potential battery depletion.She stated her device has not been checked in a year.An estimate of battery life calculation was performed and did not support battery depletion.Additional relevant information has not been received to-date.

Event Description

Information was received providing the patient was referred for replacement surgery.Generator replacement surgery occurred.The explant facility does not return devices to the manufacturer.The physician provided that the increase in depression was not higher than before the patient had vns and the increase in depression was related to the vns, and that the device was at end-of-life.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7776421
• MDR Text Key: 116872964
• Report Number: 1644487-2018-01379
• Device Sequence Number: 1
• Product Code: MUZ
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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: 06/30/2007
• Device Model Number: 102R
• Device Lot Number: 013834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2005
• 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: 75 YR