FDA Adverse Event
Death
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 7727234
·
Received July 27, 2018
Report
- Report Number
- 2649622-2018-12293
- Event Type
- Death
- Date Received
- July 27, 2018
- Date of Event
- July 22, 2018
- Report Date
- October 4, 2018
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 IS DECEASED. PHYSICIAN REPORTED OVERSENSING NOISE ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL AND MULTIPLE SHOCK THERAPIES WERE DELIVERED FROM THE COMPETITOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568390 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |