FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3990927
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08394
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD COULD NOT PASS PAST THE UPPER SUPERIOR VENA CAVA (SVC) DURING THE IMPLANT PROCEDURE. THE RV LEAD WAS NOT IMPLANTED AND A NEW LEAD IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471272 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR |