MAUDE Adverse Event Report: UNKNOWN RIATA LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7020

Device Problems Fracture (1260); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Patient has fractured ria ta lead.On review of carealert report, patient was found to have rv defib impedance alert triggered due to impedance measurement of >200 ohms relative to an alert threshold of 200 ohms on (b)(6) 2021 (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RIATA LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531737
• MDR Text Key: 321431011
• Report Number: MW5138650
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2021

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?: No
• Device Model Number: 7020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1