FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO
MDR report key: 3992517
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09839
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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: 693565 LEAD IMPLANTED: 2009-(B)(6); 1388T LEAD IMPLANTED: 2003-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS TWO LEADS THAT RESIDE IN THE RIGHT VENTRICLE. THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED ELEVATED SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA EPISODES WITH NOISE. THE RV LEADS CURRENTLY REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 468670 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | D154AWG ICD |