FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3990490
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02243
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 229047 ANALYZER. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; TOUCH PEN AND CURSOR ARROW DO NOT LINE UP; OVERLAY/BEZEL ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. IT IS NOTED COATING/PAINT WAS FLAKING OFF OF BEZEL OVERLAY.
Description of Event or Problem · 1
IT WAS REPORTED THE CALIBRATION OF THE TOUCH PEN IS OFF. THE TOUCH PEN WAS REPLACED, BUT CANNOT GET IT TO CALIBRATE CORRECTLY. 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 |
|---|---|---|---|---|---|---|---|
| 472589 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 RADIO FREQUENCY HEAD |