MAUDE Adverse Event Report: UNKNOWN DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 4041

Device Problem Low impedance (2285)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Intermittent and low impedance of the ela swift 4041 rv lead.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531915
• MDR Text Key: 321429033
• Report Number: MW5138826
• Device Sequence Number: 1
• Product Code: MRM
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4041
• Patient Sequence Number: 1