FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4162440
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12764
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 8, 2014
- Report Date
- July 11, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 419378 LEAD IMPLANTED: 2002-(B)(6), 5076-52 LEAD, IMPLANTED: 2002-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE. THERE WAS A LEAD INTEGRITY WARNING ON THE RIGHT VENTRICULAR (RV) LEAD FOR OVERSENSING AND SHORT INTERVAL COUNTS (SIC). THE LV LEAD WAS PROGRAMMED OFF AND THE RV LEAD 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 |
|---|---|---|---|---|---|---|---|
| 639793 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | D224TRK ICD |