FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3990130
·
Received August 7, 2014
Report
- Report Number
- 2182208-2014-02265
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Report Date
- June 6, 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. 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. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE CABLE JACKET IS CUT NEAR RF (RADIO FREQUENCY) HEAD. ANALYSIS ALSO FOUND THE RF HEAD LENS IS CRACKED IN THE UPPER CASE. IT IS NOTED THE RF HEAD PASSED FUNCTIONAL TEST AND INTERROGATED A DEVICE WITHOUT ISSUE. (B)(4).
Description of Event or Problem · 1
THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462943 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |