FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2811125
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03784
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 4, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- 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. EVALUATION SUMMARY: (B)(4): PROGRAMMER BOOTS TO A SYSTEM ERROR. A PRINTED CIRCUIT BOARD FOUND OUT OF ELECTRICAL SPECIFICATION. SYSTEM FAN IS NOISY.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON POWER UP THE PROGRAMMER DISPLAYED AN ERROR CODE . THE SERVICE DISKETTE WAS RUN TO CLEAR THE ERROR, BUT IT DID NOT WORK. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2067 PROGRAMMER RF HEAD| 2290 PACING SYSTEM ANALYZER |