FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
MDR report key: 2952689
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00212
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 17, 2012
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- DXY
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE PROGRAMMER WOULD NOT POWER ON, THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS REPLACED AND CALIBRATED TO RESOLVE THIS ISSUE. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS INTERMITTENTLY NOISY.
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 AFTER BEING CONNECTED TO THE POWER SOURCE THE PROGRAMMER WAS UNABLE TO BE TURNED ON. IT WAS FURTHER REQUESTED THAT THE PROGRAMMER BE UPGRADED TO WIRELESS CAPABILITY. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57145 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MANUFACTURING | 2090AM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |