FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2607286
·
Received June 11, 2012
Report
- Report Number
- 2182208-2012-01939
- Event Type
- Malfunction
- Date Received
- June 11, 2012
- Date of Event
- March 19, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 AN ERROR OCCURRED WHEN PRINTING REPORT FOR VITATRON DEVICE. THE PROGRAMMER REMAINS IN SERVICE. NO INFORMATION WAS RECEIVED INDICATING 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 |