CROME VR ICD MRI SURESCAN

Report

• Report Number: MW5164504
• Event Type: Injury
• Date Received: January 9, 2025
• Date of Event: November 29, 2024
• Report Date: January 7, 2025
• Manufacturer: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT/MEDTRONIC INC.
• Product Code: LWS
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Location: CA, US
• Reporter Occupation: OTHER
• Health Professional: *

Narratives

Description of Event or Problem · 0

A HOSPITAL IMPLANT REGISTRATION FORM WAS RECEIVED. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT RECEIVED AN ICD SYSTEM EXTRACTION DUE TO INFECTION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5164505. REFER TO ADD'L DOCUMENTS IN I2K.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1224061	CROME VR ICD MRI SURESCAN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)	LWS	MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT/MEDTRONIC INC.	DVPC3D1

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown

Terms

Patient problem · 2

• Failure of Implant
• Unspecified Infection

Type of report · 1

• Initial submission