FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2811826
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03833
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 18, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S145
- 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
THE SALES REPRESENTATIVE (SR) REPORTED THAT THE STYLUS WAS REPLACED ON THE PROGRAMMER, AND IT WAS OUT OF CALIBRATION. TECHNICAL SUPPORT (TS) EXPLAINED HOW TO ACCESS THE 'STYLUS CALIBRATION PROGRAM' ON THE PROGRAMMER. THE PROGRAM WAS RAN, AND THE STYLUS CALIBRATION WAS CORRECTED AND FUNCTIONALLY GOOD. THE PROGRAMMER REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER | NVZ | MEDTRONIC, INC. | 2090X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |