FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S MRI SURESCAN
MDR report key: 9996217
·
Received April 24, 2020
Report
- Report Number
- 2649622-2020-08260
- Event Type
- Malfunction
- Date Received
- April 24, 2020
- Date of Event
- April 3, 2020
- Report Date
- April 24, 2020
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00613994446350
- 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: DDMB1D1 ICD, IMPLANTED: (B)(6) 2018. 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¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). THE RV LEAD EXHIBITED SEVERAL NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND HIGH RATE NON-SUSTAINED EPISODES DUE TO T-WAVE OVERSENSING (TWOS). THE RV LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 460679 | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693565 | 00613994446350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 407652 LEAD |