CARELINK
Report
- Report Number
- 2182208-2014-02206
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT, THE PROGRAMMER WAS ON AND SUDDENLY SHUT OFF AND WOULD NOT RESTART, AND THE POWER SUPPLY WAS THEREFORE REPLACED. IT WAS FURTHER NOTED THAT THE TAB HAD BROKEN OFF OF THE POWER CORD BAY DOOR AND THE POWER CORD BAY WAS ALSO REPLACED. (B)(4).
IT WAS REPORTED THAT THE PROGRAMMER SCREEN SUDDENLY TURNED BLACK AND THAT THE PROGRAMMER WAS UNABLE TO BE SUCCESSFULLY REBOOTED. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PROGRAMMER SCREEN SUDDENLY TURNED BLACK AND THAT THE PROGRAMMER WAS UNABLE TO BE SUCCESSFULLY REBOOTED. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470290 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067L RADIOFREQUENCY PROGRAMMER HEAD| 2067L RADIOFREQUENCY PROGRAMMER HEAD |