FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3153745
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06197
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- April 21, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD - 2013 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WITHIN A FEW DAYS OF IMPLANT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPOSITIONED, AND REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 257680 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE DEFIBRILLATOR |