FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2130990
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00882
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 25, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
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): ANALYSIS FOUND AN ERROR MESSAGE AT BOOT-UP, CAUSED BY A SOFTWARE ISSUE. THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CLINIC WAS HAVING "PROBLEMS" WITH THE PROGRAMMER. IT WAS ALSO REPORTED THE PROGRAMMER WAS NOT FUNCTIONING. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER | KRG | MEDTRONIC, INC. | 2090 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2067 PROGRAMMER RF HEAD |