FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
MDR report key: 3990785
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02224
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 23, 2014
- Report Date
- June 2, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS SENSING NOISE DUE TO ELECTROMAGNETIC/AC INTERFERENCE. THE DEVICE REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471355 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC, INC. | MDT-UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |