FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 8689403
·
Received June 11, 2019
Report
- Report Number
- 2649622-2019-10004
- Event Type
- Injury
- Date Received
- June 11, 2019
- Date of Event
- May 16, 2019
- Report Date
- June 11, 2019
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: DTMA1D1 CRT-D, 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 HAD SIGNIFICANT UNDERSENSING OF R-WAVES WITH THE PATIENT REQUIRING EXTERNAL RESCUE. THE PATIENT HAS HAD FAILING CARDIO-PULMONARY HEALTH WITH A RECENT ACCUMULATION OF FORTY POUNDS OF BODY FLUID. THE SENSITIVITY OF THE RIGHT VENTRICULAR LEAD WAS REPROGRAMMED. THE 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 |
|---|---|---|---|---|---|---|---|
| 482079 | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Life Threatening| R |