FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 3152286
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06889
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 18, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK DUE TO A RIGHT VENTRICULAR LEAD FRACTURE. IT WAS FURTHER REPORTED THAT THERE WAS HIGH LEAD IMPEDANCE AND LOSS OF CAPTURE. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252968 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | D354TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |