FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2791686
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03538
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 20, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. 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. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT. A PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER GENERATED ERROR MESSAGE. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR SERVICE, ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK PROGRAM W/TELEMETRY C | PROGRAMMER | DXY | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2067 PROGRAMMER RF HEAD| 2290 PACING SYSTEM ANALYZER |