FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2131711
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-01010
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 21, 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 THAT THE DEVICE WOULD NOT INTERROGATE, THE CABLE WAS OUT OF ELECTRICAL SPECIFICATION.
Description of Event or Problem · 1
ASKU
Description of Event or Problem · 1
IT WAS REPORTED THE RF PROGRAMMER HEAD WOULD NOT RECOGNIZE DEVICES AND LOAD SOFTWARE FROM THE START-UP SCREEN. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER RF HEAD | KRG | MEDTRONIC, INC. | 2067 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |