FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3153280
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05917
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO INTERMITTENT EPISODES OF T-WAVE OVERSENSING (TWOS). IT WAS THOUGHT IT MAY BE EXERCISE RELATED T-WAVE ELEVATION. CORRECTABLE MEDICAL REASONS FOR THE TWOS AND REPROGRAMMING WERE CONSIDERED. THE RV LEAD IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 255221 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |