FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3152353
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06853
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 24, 2013
- Report Date
- April 26, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST -OPERATIVE THE RIGHT VENTRICULAR (RV) LEAD HAD HIGHLY VARIABLE R-WAVES AND LACK OF SLACK VISIBLE ON X-RAY. THEREFORE THE RV LEAD WAS REVISED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252984 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| S | D314DRG IMPLANTABLE PACEMAKER CARDIO/DEFIB |