FDA Adverse Event Malfunction Summary report: N

CLARIA MRI QUAD CRT-D SURESCAN

MDR report key: 19220273 · Received May 1, 2024

Report

Report Number: 3004209178-2024-10078
Event Type: Malfunction
Date Received: May 1, 2024
Date of Event: April 10, 2024
Report Date: May 1, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: NIK
UDI-DI: 00643169837669
PMA / PMN Number: P010031
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: 0185 LEAD, IMPLANTED (B)(6) 2005. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT IS ON HOSPICE WITH A MAGNET PLACED OVER THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IT WAS NOTED THAT THE PATIENT HAS A HEART RATE IN THE TWENTIES. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
172323	CLARIA MRI QUAD CRT-D SURESCAN	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC PUERTO RICO OPERATIONS CO.	DTMA1Q1		00643169837669

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR	Male		459888 LEAD