FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4970992
·
Received August 5, 2015
Report
- Report Number
- 2649622-2015-09737
- Event Type
- Injury
- Date Received
- August 5, 2015
- Date of Event
- March 10, 2015
- Report Date
- May 6, 2015
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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. CONCOMITANT PRODUCTS: 5076-45, LEAD, IMPLANTED: (B)(6) 2008. 419688 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE DUE TO FRACTURE. THERE WAS A RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) RISE NOTED ON THE LEAD TREND. ADDITIONALLY, THE LEAD ALERT FOR HIGH IMPEDANCE TRIGGERED ON TWO OCCASIONS. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513103 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | Hospitalization| R | D314TRM DEVICE |