ATTAIN PERFORMA MRI SURESCAN
Report
- Report Number
- 2649622-2025-29868
- Event Type
- Injury
- Date Received
- October 23, 2025
- Date of Event
- September 29, 2025
- Report Date
- October 23, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO VILLALBA
- Product Code
- OJX
- UDI-DI
- 00643169601826
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
CONTINUATION OF D10: 2088 LEAD AND TENDRIL LEAD IMPLANTED: (B)(6) 2019 B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. 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.
IT WAS REPORTED BY THE PATIENT THAT APPROXIMATELY A MONTH AFTER IMPLANT, THE LEFT VENTRICULAR (LV) LEAD ¿CAME OUT¿. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1506090 | ATTAIN PERFORMA MRI SURESCAN | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P | OJX | MEDTRONIC PUERTO RICO VILLALBA | 429878 | 00643169601826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention| H | W4TR01 CRTP. |