FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 1923007
·
Received December 13, 2010
Report
- Report Number
- 2182208-2010-00963
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 7, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO NOISE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH PACING IMPEDANCE. THE LEAD WAS ABANDONED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED 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, INC. | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |