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

Model Number 106

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/20/2019

Event Type  Injury  

Event Description

It was reported that the patient had an increase in seizures for the past few months, and the patient was found to have high impedance when interrogated.She was referred for x-rays and a ct scan.The ct scan has not been sent to livanova to date.When the patient was implanted in (b)(6) 2018, their impedance was within normal limits.Ap chest x-rays were received for the patient.Based on the images provided, the pin did not appear to be through the second connector block, indicating incomplete pin insertion.The integrity of the feedthrough wires and lead wires at the connector pin appeared normal.The lead was observed in the chest.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.There was a portion of the lead that appeared to be placed behind the generator with no visualization of damage.Based on the images provided, the high impedance was likely due to incomplete pin insertion.Note that the portions of the system that were not present in the images could not be assessed and the presence of micro-fractures could not be ruled out.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.

Event Description

The patient underwent pin reinsertion surgery, which resolved the high impedance.No additional or relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8510680
• MDR Text Key: 141806773
• Report Number: 1644487-2019-00651
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2019
• Device Model Number: 106
• Device Lot Number: 204043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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): Other
• Patient Age: 56 YR