FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3861951
·
Received June 10, 2014
Report
- Report Number
- 2182208-2014-01736
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- April 14, 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
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE STYLUS WOULD NOT ALIGN WITH THE ARROW ON THE SCREEN, AS A RESULT THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. IT WAS ALSO NOTED THAT THE LATCH TABS ON THE POWER CORD BAY DOOR WERE BROKEN AND THE PAPER GUIDE ON THE PRINTER DRAWER WAS MISSING. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337193 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067L RADIOFREQUENCY (RF) HEAD |