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

Model Number 105

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

Patient Problem Seizures (2063)

Event Date 01/02/2020

Event Type  Injury  

Event Description

Patient reported being in the emergency room due to 2 episodes during which the patient felt like she was having a seizure or stroke.The patient reported that she put the magnet over the generator and this stopped the event.Further information was received that the patient¿s device was disabled.A ct scan was performed and no stroke was observed on the scan.The emergency room doctor reported that he felt the cause of the event was the device.It was further noted that the patient does not have epilepsy or seizures.No other relevant information has been received to date.

Event Description

It was determined from new information received that the increase in seizures was likely related to the patient's high impedance that has been reported in mfr report# 1644487-2020-00283.Therefore, all further investigation will be completed in mfr report# 1644487-2020-00283.

• Brand Name: PULES 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: 9627882
• MDR Text Key: 176262551
• Report Number: 1644487-2020-00109
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

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: 11/12/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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: 64 YR