FDA Adverse Event
Malfunction
Summary report: N
PACEART SYSTEM
MDR report key: 2130784
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00875
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 19, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DPS
- PMA / PMN Number
- K024278
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THE CLIENT WAS UNABLE TO OPEN THE CARELINK WEBSITE. A BLANK SCREEN WOULD APPEAR AND THE WEBSITE WOULD NOT APPEAR. FOLLOW-UP CONCLUDED THAT ISSUE CLEARED ON ITS OWN. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACEART SYSTEM | SOFTWARE | DPS | MEDTRONIC, INC. | GCII | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |