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

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2020

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's generator.No further relevant information has been received to date.No further relevant surgical intervention has occurred to date.

Event Description

It was reported by the physician that they didn't remember the case they reported and that (at the time of this report) all of the patient's were fine, implying that either the event didn't occur or had resolved.No further relevant information has been received to date.

• Brand Name: LEAD MODEL UNK
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11119480
• MDR Text Key: 225534340
• Report Number: 1644487-2021-00026
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1