FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4161322
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02709
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 14, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED ERROR AT BOOT UP; PROGRAMMER BOOTS TO A SYSTEM ERROR. ANALYSIS ALSO FOUND THE KEYBOARD SLIDE COVER IS MISSING. LEFT KEYBOARD HINGE AND KEYBOARD LATCH ARE BROKEN. STYLUS TIP IS PULLING AWAY FROM MAIN PEN BODY. CONCOMITANT PRODUCT: 229047 ANALYZER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER RECEIVED AN ERROR DURING BOOT UP. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638160 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067L RADIO FREQUENCY HEAD |