FDA Adverse Event
Injury
Summary report: N
ASSURITY MRI
MDR report key: 23297465
·
Received October 15, 2025
Report
- Report Number
- 2017865-2025-1002693
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 28, 2025
- Report Date
- November 6, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- UDI-DI
- 05414734509589
- PMA / PMN Number
- P140033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: H6.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1002694. IT WAS REPORTED A PATIENT'S PACEMAKER AND INSERTABLE CARDIAC MONITOR (ICM) PRESENTED WITH AN ELECTROGRAM (EGM) ANOMALY AND UNDER-SENSING. NO CHANGES WERE REPORTED. THE PATIENT STATUS WAS UNKNOWN, BUT THE PATIENT WAS INTUBATED AND SEDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358476 | ASSURITY MRI | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | PM2272 | A000178310 | 05414734509589 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Required Intervention | ATRIAL LEAD.| RIGHT VENTRICULAR (RV) LEAD. |