FDA Adverse Event
Malfunction
Summary report: N
SELECTSECURE MRI SURESCAN
MDR report key: 9716777
·
Received February 17, 2020
Report
- Report Number
- 2649622-2020-03469
- Event Type
- Malfunction
- Date Received
- February 17, 2020
- Date of Event
- January 24, 2020
- Report Date
- February 17, 2020
- Manufacturer
- MPRI
- Product Code
- NVN
- UDI-DI
- 00763000130800
- PMA / PMN Number
- P030036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS FEELING "SWIMMY" NOT LIKE PASSING OUT BUT LIGHTHEADED AT TIMES. INTERMITTENT HIS CAPTURE IS SUSPECTED. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179913 | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 383069 | 00763000130800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |