ATTAIN STABILITY QUAD MRI SURESCAN
Report
- Report Number
- 2649622-2025-30016
- Event Type
- Death
- Date Received
- October 24, 2025
- Date of Event
- October 14, 2025
- Report Date
- February 26, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO VILLALBA
- Product Code
- OJX
- UDI-DI
- 00643169860421
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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.
PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. 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.
CONTINUATION OF D10: 383069 LEAD IMPLANTED: (B)(6) 2024. 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.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE IMPLANT PROCEDURE DID NOT HAVE ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME AND DEVELOPED VENTRICULAR FIBRILLATION (VF). THE PHYSICIAN DID NOT FEEL THAT THERE WERE ANY ISSUES WITH THE IMPLANT PROCEDURE OR ANY RELATIONSHIP BETWEEN THE DEVICE SYSTEM AND THE PATIENT DEATH.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM), RESULTING IN DELAY IN EPISODE DETECTION AND EARLY EPISODE TERMINATION. IT WAS ALSO REPORTED THAT POST IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEFT VENTRICULAR (LV) LEAD, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2027827 | ATTAIN STABILITY QUAD MRI SURESCAN | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MEDTRONIC PUERTO RICO VILLALBA | 479888 | 00643169860421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Death | W4TR01 CRT-P, 6725 ADAPTOR |