FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 10134177
·
Received June 9, 2020
Report
- Report Number
- 2649622-2020-10888
- Event Type
- Malfunction
- Date Received
- June 9, 2020
- Date of Event
- May 6, 2020
- Report Date
- June 9, 2020
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MODEL: UNKNOWN COMPETITOR CRT-D. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596719 | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5076-52, LEAD / 419475, LEAD |