FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 3860226
·
Received June 10, 2014
Report
- Report Number
- 2649622-2010-05502
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 9, 2010
- Report Date
- February 25, 2024
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343654 | SPRINT QUATTRO SECURE MRI SURESCAN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Hospitalization| R |