FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2790229
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03435
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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 CONFIRMED THE REPORTED EVENT. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE CIRCUIT BOARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER WILL NOT ACCEPT NEW SOFTWARE WHILE CONNECTED TO THE SOFTWARE DOWNLOAD NETWORK. THE PROGRAMMER WAS RETURNED FOR SERVICING. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |