FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4160811
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02795
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 31, 2014
- Report Date
- July 31, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM DISPLAY OR INTERROGATION ISSUES. PROGRAMMER PASSED FUNCTIONAL TESTING. PROGRAMMER INTERROGATES A DEVICE WIRELESSLY. PROGRAMMER INTERROGATES A DEVICE NON-WIRELESSLY WITH A KNOWN GOOD RF (RADIO FREQUENCY) HEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER HAS SCREEN PROBLEMS (LINES ACROSS SCREEN, FLUTTERING, ETC). UNABLE TO INTERROGATE DEVICES PROPERLY. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641450 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 RADIO FREQUENCY HEAD |