SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2013-06171
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- April 3, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THAT THERE WAS HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATION (DEFIB) IMPEDANCE. THERE WERE THREE PATIENT ALERTS FOR OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2013. THE WEEKLY HV (HIGH VOLTAGE) LEAD TREND DATA SHOWS AN INCREASE FOR MIN AND MAX SVC DEFIB EQUAL TO 59 TO 13 ,136 OHMS RANGE BETWEEN (B)(6) 2012 AND (B)(6) 2013. CONCOMITANT PRODUCTS: 507645 IMPLANTABLE PACING LEAD - (B)(6) 2007. (B)(4).
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IS SUSPECTED TO BE FRACTURED AS THE LEAD'S SUPERIOR VENA CAVA (SVC) IMPEDANCE HAS BEEN TRENDING UPWARDS AND HAS CONSISTENTLY MEASURED HIGH OVER THE LAST FOURTEEN DAYS. THE LEAD REMAINS IN USE AS THE PHYSICIAN PLANS TO PERFORM VENTRICULAR FIBRILLATION (VF) INDUCTION TESTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254950 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |