FDA Adverse Event Injury Summary report: N

ATTAIN ABILITY PLUS MRI SURESCAN

MDR report key: 24215049 · Received January 29, 2026

Report

Report Number: 2649622-2026-02779
Event Type: Injury
Date Received: January 29, 2026
Date of Event: January 8, 2026
Report Date: January 29, 2026
Manufacturer: MEDTRONIC PUERTO RICO VILLALBA
Product Code: OJX
UDI-DI: 00643169860131
PMA / PMN Number: P080006
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: M7700-29 MECHANICAL VALVE, IMPLANTED: (B)(6) 1989, A7700-21 MECHANICAL VALVE IMPLANTED: (B)(6) 1989. 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 PATIENT EXPERIENCED BOTH DIAPHRAGMATIC AND PHRENIC NERVE STIMULATION POST IMPLANT PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
278352	ATTAIN ABILITY PLUS MRI SURESCAN	DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P	OJX	MEDTRONIC PUERTO RICO VILLALBA	429688		00643169860131

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR	Male	Hospitalization\| R	SEE H11