FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3860021
·
Received June 10, 2014
Report
- Report Number
- 2182208-2014-01537
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 20, 2014
- Report Date
- April 20, 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
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER DID NOT BOOT UP AND THE HARD DRIVE WAS THEREFORE REIMAGED AND THE SOFTWARE LOADED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER DID NOT BOOT UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER DID NOT BOOT UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341800 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |