MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 09/12/2019

Event Type  Injury  

Event Description

The physician reports that the patient feels the vns going off almost hourly, but the discomfort level is "tolerable" and she is able to sleep through the night.The physician decided to replace her current vns as they believed that the device was "malfunctioning." the patient's device was explanted and replaced due to "prophylactic" battery replacement.The explanted product has been received by the manufacturer; however, the analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

Further follow up with the neurologist's office confirmed that the device was checked the date the patient presented with discomfort and altered perception of stimulation; however, that the adverse events did not present until after the patient left the office.The physician informed that during this appointment the vns diagnostics were tested and were confirmed to be within normal limits.Additionally, the vns output frequency was increased from 10hz to 15hz.It was not until after the patient had left the neurologist's office the patient began to experience the symptoms of erratic stimulation, painful stimulation, and coughing.At this point in time, the vns was not re-checked, and the neurologist ultimately decided to refer for prophylactic generator change to upgrade patient from a m102 to m106.No further details were provided from the neurologist¿s office.The explanted generator underwent product analysis, and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters, and the generator battery status was ok.There were no performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 9162124
• MDR Text Key: 161402739
• Report Number: 1644487-2019-01944
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 11/01/2019

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: 08/09/2012
• Device Model Number: 102
• Device Lot Number: 2773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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): Required Intervention
• Patient Age: 29 YR