FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2811357
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-17099
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUPERIOR VENA CAVA COIL IMPEDANCE HAD BEEN HIGH FROM IMPLANT FORWARD. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. MEASUREMENTS FOR THE RV LEAD WERE NORMAL AT THE TIME OF REPLACEMENT. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4574 IMPLANTABLE PACING LEAD |