FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2201346
·
Received August 11, 2011
Report
- Report Number
- 2182208-2011-01182
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 6, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S080
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THAT THE PROGRAMMER WOULD NOT FULLY BOOT THE MAIN SCREEN. A SERVICE DISKETTE WAS REQUESTED TO CLEAR THE ERROR. IF THE ISSUE PERSISTS THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK PROGRAM W/TELEMETRY C | PROGRAMMER | DXY | MEDTRONIC, INC. | 2090W | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |