FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2790399
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03453
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE PROGRAMMER HEAD WAS RETURNED AND ANALYSIS FOUND THE CABLE TO BE OUT OF SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "AUTO IDENTIFY WAS NOT IDENTIFIED" WITH THE RADIO FREQUENCY PROGRAMMER HEAD. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. NO PATIENT INVOLVEMENT WAS INDICATED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER RF HEAD | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2290 PACING SYSTEM ANALYZER| (B)(4) PROGRAMMER |