FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2791369
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03512
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 10, 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. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE POWER SUPPLY WAS OUT OF SPECIFICATION, DUE TO THIS CONDITION THE PROGRAMMER WAS UNABLE TO POWER UP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT POWER ON, DESPITE CHANGING OUT THE POWER CORD AND TRYING A DIFFERENT POWER OUTLET. IT WAS FURTHER REPORTED THAT THE FANS ALSO DID NOT TURN ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS ALSO INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH 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 | 2067 PROGRAMMER RF HEAD |