FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 2811923
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03834
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- 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
IT WAS REPORTED THAT A COMPETITOR RECEIVED INFORMATION THAT THE PROGRAMMER IS DETERIORATING AND NEEDS TO BE REPLACED DUE TO NEEDING TO INTERROGATE A PATIENT'S TRIUMPH DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | PROGRAMMER | KRG | MEDTRONIC, INC. | 2037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |