FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2813067
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03868
- Event Type
- Malfunction
- Date Received
- October 31, 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
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE UPPER CASE LENS WAS BROKEN. IT WAS ALSO NOTED THAT THE DEVICE FAILED THE UPLINK AND ELECTROMAGNETIC FIELD IMMUNITY TESTS DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION.
Description of Event or Problem · 1
THE RADIOFREQUENCY (RF) HEAD WAS RETURNED FOR SERVICING. THE RF HEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF 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 | 2090W PROGRAMMER |