FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3153732
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06186
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 11, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 PRODUCT: 4196 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC AFTER HEARING AN ALERT TONE. THE SUPERIOR VENA CAVA (SVC) COIL HAD HIGH IMPEDANCE. THE SVC WAS PROGRAMMED OFF PER PHYSICIAN'S ORDER. A LEAD REVISION IS BEING DISCUSSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254917 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR | Required Intervention | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |