FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3152861
·
Received June 8, 2013
Report
- Report Number
- 2182208-2013-01361
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003
- 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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE DEVICE WAS NOT FUNCTIONAL, THE PROGRAMMER POWERED UP TO A BLANK SCREEN OR A SYSTEM ERROR. AS A RESULT PIN RECONFIGURATION WAS COMPLETED AND SOFTWARE WAS RELOADED TO RESOLVE. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE, THE SYSTEM FAN WAS INTERMITTENTLY NOISY AND THE PRINTER ERRONEOUSLY DISPLAYED THAT IT WAS OUT OF PAPER.
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER IS "TOTALLY NON-FUNCTIONAL." THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254995 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD |