FDA Adverse Event
Injury
Summary report: N
CARELINK
MDR report key: 2131214
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00900
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- April 8, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S065
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KZ
- 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 DURING AN IMPLANT ATTEMPT, WHILE TRYING TO TAKE MEASUREMENTS WITH THE ANALYZER, THE PROGRAMMER SCREEN "BECAME WHITE" AND THE ANALYZER SCREEN DID NOT DOWNLOAD AND THEN THE PROGRAMMER FROZE. THE PROGRAMMER HAD TO BE SWITCHED OFF TO CONTINUE THE IMPLANT. THE ANALYZER IS BEING SENT TO THE COMPANY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PACING SYSTEM ANALYZER | DXY | MEDTRONIC, INC. | 2290 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |