FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
MDR report key: 3152684
·
Received June 7, 2013
Report
- Report Number
- 2182208-2013-01535
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 11, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO PROGRAMERS WERE UNABLE TO INTERROGATE THE RECENTLY IMPLANTED CARDIAC DEVICE. THE CALLER INDICATED THAT THE PATIENT WAS MOVED TO ANOTHER ROOM, AND ADDED DISTANCE BETWEEN THE DEVICE AND PROGRAMMING HEAD, STILL WITHOUT TELEMETRY POSSIBLE. THE COMPANY REPRESENTATIVE RETRIEVED ANOTHER PROGRAMMER AND WAS ABLE TO INTERROGATE THE DEVICE. AFTER THE SESSION ENDED, THE TWO PROGRAMMERS THAT HAD BEEN TRIED, WERE THEN ABLE TO INTERROGATE THE DEVICE. THE PROGRAMMERS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253229 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR |