FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2130888
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10289
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, 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 HAD INAPPROPRIATE HIGH VOLTAGE THERAPIES DUE TO NOISE SENSING. THE LEAD WAS CAPPED AND REPLACED WITH ANOTHER ONE. 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 PUERTO RICO, INC. | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 4574 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |