FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2952076
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00123
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 5, 2012
- Report Date
- January 10, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; BEZEL ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TOUCH PEN COULD NOT BE CALIBRATED TO THE SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPL ICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56017 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 PROGRAMMER RF (RADIO-FREQUENCY HEAD) |