FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3991191
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08256
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 16, 2014
- Manufacturer
- MPRI
- Product Code
- NVY
- 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. CONCOMITANT MEDICAL PRODUCTS: 5076 LEAD, IMPLANTED (B)(6) 2014; 4396 LEAD, IMPLANTED (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. AN X-RAY CONFIRMED THAT THE LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467762 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Hospitalization| R | DTBA1D4 ICD |