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 Arrhythmia (1721)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported the patient had a lead revision due to lead fracture.When the replacement lead was implanted and system diagnostics was performed, the patient went into asystole.It was noted that intervention was taken and the patient was able to be stabilized and the procedure was completed.Lead fracture was previously reported in mfr report #: 1644487-2020-01139.No additional relevant information has been received to date.

Event Description

It was reported that when preliminary testing of the lead was performed at full dosage, the patient went into asystole for a few seconds.The stimulation was stopped and the patient came back to sinus rhythm.The testing dosage was halved and no additional issues were observed.Per the physician, asystole occurred because of the vns stimulation being delivered during the testing.No additional 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
• MDR Report Key: 10847441
• MDR Text Key: 216573315
• Report Number: 1644487-2020-01539
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/13/2019
• Device Model Number: 106
• Device Lot Number: 204113
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR