FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3862384
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06962
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 9, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 A RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WITH HIGH SHORT INTERVAL COUNTS (SIC) AND INSULATION DAMAGE WAS DISCOVERED BY THE PHYSICIAN AT THE TIME OF EXPLANT. THE LEAD HAS BEEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338103 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR | Hospitalization| R | D154VRC, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |