FDA Adverse Event Death Summary report: N

SPRINT QUATTRO SECURE S MRI SURESCAN

MDR report key: 23037641 · Received September 12, 2025

Report

Report Number: 2649622-2025-25333
Event Type: Death
Date Received: September 12, 2025
Date of Event: August 14, 2025
Report Date: September 12, 2025
Manufacturer: MEDTRONIC PUERTO RICO VILLALBA
Product Code: LWS
UDI-DI: 00643169356566
PMA / PMN Number: P920015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED OVERSENSING AND DOUBLE COUNTING OF WIDE VENTRICULAR COMPLEX RHYTHMS DURING HIGH-RATE NON-SUSTAINED EPISODES. ADDITIONALLY, THE RV LEAD WAS SUSPECTED TO HAVE DISPLAYED INTERMITTENT CAPTURE. A WELLNESS CHECK WAS ADVISED AND THE PATIENT'S CLINIC INDICATED THAT THEY WERE INFORMED BY A PATIENT REPRESENTATIVE THAT THE PATIENT HAD PASSED AWAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2305567	SPRINT QUATTRO SECURE S MRI SURESCAN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)	LWS	MEDTRONIC PUERTO RICO VILLALBA	6935M62		00643169356566

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR	Male	Death	DDPA2D4 ICD, 407652 LEAD.