FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4162895
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-03045
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 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 THE REPORTED EVENT; ABLE TO USE AND CALIBRATE STYLUS WITH NO FAULT FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STYLUS WOULD NOT CALIBRATE. ANOTHER PROGRAMMER HAD TO BE USED TO COMPLETE THE INTERROGATION. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639012 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 RADIO FREQUENCY HEAD |