FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
MDR report key: 2965065
·
Received February 15, 2013
Report
- Report Number
- 2182208-2013-00424
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- November 14, 2012
- Report Date
- November 14, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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; A PRINTED CIRCUIT BOARD WAS FOUND OUT OF ELECTRICAL SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS ECG (ELECTROCARDIOGRAM) NOISE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67797 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |