FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4160860
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02791
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- June 6, 2014
- Report Date
- July 1, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- 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 ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE RF (RADIO FREQUENCY) HEAD FAILED UPLINK FUNCTIONAL TESTS AND WAS NOT ABLE TO INTERROGATE. THE RF HEAD CABLE INSULATION FOUND CUT AND THE RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RF HEAD LABEL IS MISSING LAMINATE. (B)(4).
Description of Event or Problem · 1
THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640771 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090 PROGRAMMER |