FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2813373
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03824
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 16, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER WOULD NOT BOOT AND HANGS IN A BIOS (BASIC INPUT-OUTPUT SYSTEM) SCREEN. THE KEYBOARD AND RF (RADIO FREQUENCY) HEAD CONNECTOR WERE REMOVED, THE PROGRAMMER WAS REBOOTED, AND THE PROGRAMMER THEN BOOTED AS IT SHOULD. THE PROGRAMMER WAS RESTORED TO SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK PROGRAM W/TELEMETRY C | PROGRAMMER | DXY | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |