CARELINK
Report
- Report Number
- 2182208-2014-02219
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 27, 2014
- Report Date
- June 27, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE STYLUS PEN WAS NOT TRACKING WITH THE OVERLAY SCREEN AND THEREFORE THE OVERLAY BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS CALIBRATED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PROGRAMMER'S TOUCH PEN STYLUS CALIBRATION. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PROGRAMMER'S TOUCH PEN STYLUS CALIBRATION. 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 |
|---|---|---|---|---|---|---|---|
| 469954 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 RADIOFREQUENCY PROGRAMMER HEAD| 2067 RADIOFREQUENCY PROGRAMMER HEAD |