FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2790759
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03474
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THERE WAS AN ERROR MESSAGE AT BOOT UP. IT WAS ALSO NOTED THAT THE STYLUS WOULD NOT SELECT AND THE DEVICE WOULD NOT PRINT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR MESSAGE. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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 | 2290 PACING SYSTEM ANALYZER| 2067L PROGRAMMER RF HEAD |