FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
MDR report key: 3051294
·
Received April 10, 2013
Report
- Report Number
- 2182208-2013-01053
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- July 23, 2012
- Report Date
- July 23, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE PROGRAMMER BOOTED TO A SOFTWARE ERROR AT STARTUP.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS AN ERROR AT STARTUP. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152275 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |