FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3153401
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05990
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- February 19, 2013
- Report Date
- March 29, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 2012 (B)(6); 4076 IMPLANTABLE PACING LEAD 2007 (B)(6); 4194 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE DISCRIMINATOR FAILED TO WITHHOLD THERAPY. INCREASING THE VENTRICULAR SENSITIVITY WAS DISCUSSED. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256392 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Life Threatening| R |