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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem Chest Pain (1776)

Event Date 11/28/2019

Event Type  malfunction  

Event Description

Patient presented with high lead impedance.The patient noted that they fell into a door a week prior, due to depreciated loss of eye sight.The patient noted that they feel sharp pain in chest area occasionally.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patients generator and lead were explanted.The explanted products have not been received by the manufacturer to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9496537
• MDR Text Key: 182750564
• Report Number: 1644487-2019-02482
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 12/22/2020

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: 09/18/2008
• Device Model Number: 302-20
• Device Lot Number: 1290
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR