FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4160236
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02849
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- June 12, 2014
- Report Date
- July 8, 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: DURING ANALYSIS IT WAS NOTED THAT THE ANALYZER HAD AN INTERMITTENT LOSS OF COMMUNICATION WITH THE PROGRAMMER AND FAILED FUNCTIONAL AND SYSTEMS TESTS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SOFTWARE ANALYZER ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638139 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC INC. | R2290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090W PROGRAMMER |