MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Voluntary medical device correction (remedial action) was initiated by the manufacturer on (b)(6) 2018, via physician notification letter.

Event Description

It was reported that a patient's device was showing high impedance.The patient was recently implanted with an impedance with ok impedance.It was further noted that the patient was experiencing an increase in seizures.X-rays were received but could not properly assess complete pin insertion or fracture due to image quality.An update was received that impedance was back within normal limits.No intervention was planned to date.It was noted that testing could not be performed with the patient at different conditions due to the patient's condition.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.As indicated in the physician's manual, high lead impedance (>/= 5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction.No relevant surgical intervention has occurred to date.At the time of this report it is unclear whether this event is related to this "m1000 higher impedances" issue mentioned above.No additional relevant information was received to date.

Event Description

It was stated that the patient's device was being monitored and was showing impedances within normal limits.The patient reportedly only had an increase in seizures when the impedance was showing high.There were no further updates from the office.No known surgery has occurred to date.No additional, relevant information was received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• 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: 8280495
• MDR Text Key: 134187529
• Report Number: 1644487-2019-00146
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/13/2022
• Device Model Number: 303-20
• Device Lot Number: 204486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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