FDA Adverse Event
Malfunction
Summary report: N
PACEART SYSTEM
MDR report key: 2813561
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03826
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 16, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DPS
- PMA / PMN Number
- K024278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 DATE AND TIME STAMP OF A REMOTE TRANSMISSION WAS DIFFERENT IN THE APPLICATION THAN IT WAS ON THE SYSTEM. THE CLIENT WANTED TO KNOW WHY IT WAS DIFFERENT. TECHNICAL SERVICES (TS) STARTED A REMOTE SUPPORT SESSION AND REVIEWED WHAT THE CUSTOMER WAS SEEING IN THE APPLICATION. THE ISSUE WILL BE ESCALATED FOR FURTHER INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACEART SYSTEM | SOFTWARE | DPS | MEDTRONIC, INC. | GCIII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |