FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3152463
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06778
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- April 22, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NON-PHYSIOLOGIC SENSING AND NST (NON-SUSTAINED TACHYCARDIA) EPISODES, AND THE SVC (SUPERIOR VENA CAVA) COIL WAS BELIEVED TO HAVE FRACTURED, WITH A SPIKE IN SVC IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253067 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | D274DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |