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

Model Number 105

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

Patient Problems Chest Pain (1776); Muscle Spasm(s) (1966); Pain (1994)

Event Date 11/01/2017

Event Type  Injury  

Event Description

It was reported via clinic notes received that the patient was referred for vns explantation surgery due to chest and jaw pain and the desire for mris.It was stated that the patient was seizure free for a year even with the vns disabled.Follow up revealed that the reason the vns was disabled was due to chest cramps experienced by the patient.The surgery to explant the vns was reported as both for the patient's comfort and to preclude serious injury as the patient had experienced pain and no longer used the vns.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

Product analysis was completed and approved for the returned generator.Visual examination of the device showed markings typical of surgical procedures.No other surface abnormalities were noted.Both interrogation and system diagnostic tests were performed and resulting status checks were all within normal limits.The device output signal was monitored for more than 24 hours in a simulated body temperature environment and showed no signs of variation in the output signal and demonstrated the expected level of output current.The device performed according to functional specifications and was observed to be at intensified follow indicator = no condition.There were no performance or any other type of adverse conditions found with the generator.No additional, relevant information was received to date.

Event Description

An update was received stating that the patient's generator and lead were removed at the patient's caregiver's request.No replacement device was implanted.It was stated that the patient had been seizure-free without vns for about 2-3 years.No device has been returned to date.No additional, relevant information has been received to date.

Event Description

The explanted devices were received for analysis.The lead assembly was returned in one portion with one loose tie down; the electrodes were not returned.Setscrew marks were observed on the connector pin, providing evidence of proper mechanical and electrical contact between the generator and connector pin at one point in time.Abraded openings of both the outer and inner tubing were identified in the returned lead portion.The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.These lead malfunctions will be captured in mfg report # 1644487-2019-00414.Analysis of the generator has not been completed to date.No additional, relevant information was 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: 8163186
• MDR Text Key: 130309110
• Report Number: 1644487-2018-02291
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2015
• Device Model Number: 105
• Device Lot Number: 3729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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): Required Intervention
• Patient Age: 22 YR