FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S MRI SURESCAN
MDR report key: 12280716
·
Received August 5, 2021
Report
- Report Number
- 2649622-2021-15762
- Event Type
- Malfunction
- Date Received
- August 5, 2021
- Date of Event
- November 15, 2020
- Report Date
- August 5, 2021
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00643169356566
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
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 AS PART OF THE PATIENT'S POST-OPERATION PROCEDURE A REMOTE TRANSMISSION WAS GENERATED AND REVIEWED BY QUALIFIED PERSONNEL. IT WAS DETERMINED THAT THERE HAD BEEN A SINGLE INCIDENT OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) ACCOMPANIED BY AN INCIDENT OF T-WAVE OVERSENSING (TWOS), BOTH ABOUT 8 MONTHS PRIOR TO THE TRANSMISSION. IT WAS NOTED THAT THE ICD REMAINS IN USE AND IS CURRENTLY FUNCTIONING AS DESIGNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1178259 | SPRINT QUATTRO SECURE S MRI SURESCAN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MPRI | 6935M62 | 00643169356566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | DDMB1D4 ICD, 5076-52 LEAD |