FDA Adverse Event
Summary report: N
QUATTRO SECURE S
MDR report key: 1970893
·
Received December 17, 2010
Report
- Report Number
- 1970893
- Date Received
- December 17, 2010
- Date of Event
- November 12, 2010
- Report Date
- December 17, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
RIGHT VENTRICULAR (RV) LEAD SCREW WOULD NOT DEPLOY AFTER HAVING BEEN DEPLOYED THEN RETRACTED AND REPOSITIONED. THE LEAD WAS TESTED PRIOR TO THE PROCEDURE. THE PATIENT WAS STABLE AFTER OR INTERVENTION TO REMOVE THE LEAD.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNIT DID NOT RETRACT PROPERLY====================== MANUFACTURER RESPONSE FOR STEROID ELUTING, TRIPOLAR, SCREW-IN, VENTRICULAR LEAD WITH RV DEFIBRILLATION COIL ELECTRODE., QUATTRO SECURE S======================PROVIDED THE OCTOBER 2010 MEDICAL DEVICE CORRECTION/PERFORMANCE NOTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRO SECURE S | LEAD, DEFIBRILLATION | LWS | MEDTRONIC, INC. | 6935 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |