CARELINK
Report
- Report Number
- 2182208-2013-01420
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- April 23, 2013
- Report Date
- April 23, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER DISPLAY SCREEN AND THE STYLUS WERE OUT OF ALIGNMENT. THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS CALIBRATED. (B)(4).
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER DISPLAY SCREEN AND THE STYLUS WERE OUT OF ALIGNMENT. THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS CALIBRATED. (B)(4).
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE PROGRAMMER AND THE STYLUS WERE OUT OF ALIGNMENT, AND ATTEMPTS TO RE-CALIBRATE WERE NOT SUCCESSFUL. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE PROGRAMMER AND THE STYLUS WERE OUT OF ALIGNMENT, AND ATTEMPTS TO RE-CALIBRATE WERE NOT SUCCESSFUL. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258599 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |