FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 9745671
·
Received February 24, 2020
Report
- Report Number
- 2649622-2020-03861
- Event Type
- Injury
- Date Received
- February 24, 2020
- Date of Event
- January 15, 2020
- Report Date
- March 3, 2020
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00613994249876
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: DTBA1D1 CRTD; IMPLANTED: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE. THE PATIENT HAS A LOT OF PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND THERE APPEARED TO BE SOME PVC DOUBLE COUNTING AND OVERSENSING OF PVC T-WAVE. THE PATIENT DEVELOPS A BLOCK WHEN PACING IS INHIBITED. 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 |
|---|---|---|---|---|---|---|---|
| 206732 | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 | 00613994249876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Life Threatening| R |