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 04/17/2019

Event Type  Injury  

Event Description

It was reported that the patient when the device was turned on, the patient began to have bradycardia.Additional information was received stating that the patient had not had bradycardia during the system diagnostics run, but when the device was turned up to the 2.0 ma output current setting the patient had previously been set to, there was a period of 30 seconds in which she only registered two pulses.The output current was lowered to 1.0 ma and then the patient was fine again.No additional information has been received to date.

Event Description

The physician does not believe there was any malfunction of the system but a high amperage with a lower impedance is believed to have caused higher current suddenly which led to the intraoperative adverse effect.

• 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: 8604907
• MDR Text Key: 144860609
• Report Number: 1644487-2019-00918
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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: 09/04/2020
• Device Model Number: 106
• Device Lot Number: 204633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 26 YR