FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3860330
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-05491
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 8, 2014
- Report Date
- March 8, 2014
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 CONTINUED: 5076-45 LEAD, IMPLANTED: 2012-(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH DIZZINESS. AN INTERROGATION OBSERVED T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH CAUSED RATES LESS THAN THE PROGRAMMED RATE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE DEVICE AND RV LEAD 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 |
|---|---|---|---|---|---|---|---|
| 343032 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |