MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

It was reported that the vns study patient's device was tested during an office visit on (b)(6) 2015 and both system and normal mode diagnostic results revealed high impedance.The patient noted that she had a decreased perception of stimulation on-times.No known surgical interventions have occurred to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received stating that x-rays were taken and were reported by the physician to be unremarkable.

Event Description

X-rays were provided to the manufacturer for review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

Event Description

Follow-up was received 03/01/2017 that surgery was planned to remove the device.Follow-up from the treating physician provided that on (b)(6) 2015 diagnostics for the device showed high impedance.The patient reported she did not have much sensation from the device when it was supposed to fire, when she was able to a few months prior.The device was turned off.The patient later decided she wanted the device removed.

Event Description

The device was not expected for return as it was stated to have been discarded.No additional, relevant information was received to date.

Event Description

During a call received from the patient regarding mri precautions, it was noted that the patient's generator was previously explanted.No products were received for analysis to date.No additional relevant information was received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4869576
• MDR Text Key: 18294943
• Report Number: 1644487-2015-05014
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2009
• Device Model Number: 302-20
• Device Lot Number: 1592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/30/2018; 01/07/2019
• Supplement Dates FDA Received: 08/04/2015; 03/26/2017; 05/01/2017; 12/20/2018; 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2006
• 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 Age: 49 YR