MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Death (1802)

Event Date 04/09/2018

Event Type  Death  

Event Description

A medical examiner reported that the patient had passed away and indicated that they would like to return the device.Medical examiner was also interested to know if the patient was receiving stimulation at the time of death as possible seizure related death is suspected.However, the cause of death and relation to vns therapy are unknown.No additional relevant information has been received to date.

Event Description

The explanted generator and lead were received.Analysis is pending and has not been completed to date.

Event Description

A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The abraded opening and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The pulse generator performed according to functional specifications (final configuration r-wave test).The pulse generator did show signs of premature battery depletion.This is reported in mfr.Report # 1644487-2018-01493.

• Brand Name: PULSE GEN MODEL 106
• 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: 7596907
• MDR Text Key: 110915476
• Report Number: 1644487-2018-01025
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2017
• Device Model Number: 106
• Device Lot Number: 203476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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 Outcome(s): Death
• Patient Age: 28 YR