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

Model Number 105

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Undesired Nerve Stimulation (1980); Seizures (2063)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

The patient's mother reported that she is concerned that the battery depleting "too fast''.She informed for the first 33 months of implant the device showed 67%, however now the battery has gone down to 50%, and she feels that this change in battery life is excessive.The mother additionally noted that she is not sure if vns is working since the patient is now experiencing sensations of the vns going off like it is stronger, and she says it happens several times together, but then does not happen anymore.Per the mother, the patient is not near any magnets during these events.The mother mentioned that the physician turned device down.It was noted that the patient then had a seizure and the mother wonders if it was due to vns.No other relevant information has been received to date.

Event Description

Further follow up confirmed that the physician is not concerned of the battery depleting faster than expected.Additionally, it was confirmed that the patient has received benefit with the vns therapy system, and that the patient's increased seizures were caused by severe epilepsy.The physician is unsure why the patient felt "stronger stimulation" several times in a row.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8789643
• MDR Text Key: 151001196
• Report Number: 1644487-2019-01374
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: 08/18/2019

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: 01/09/2017
• Device Model Number: 105
• Device Lot Number: 203260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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: 23 YR