FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3160370
·
Received June 10, 2013
Report
- Report Number
- 2182208-2013-01832
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS NO TELEMETRY ON THE DEVICE. IT WAS ALSO REPORTED THE PROGRAMMER DID NOT SHOW ANY GREEN LIGHTS. FOLLOW UP WITH THE PHYSICIAN¿S OFFICE WAS CONDUCTED AND IT WAS DISCLOSED THE DEVICE WAS FUNCTIONING NORMALLY. THE DEVICE REMAINS IN USE. THE STATUS OF THE PROGRAMMER IS NOT KNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261194 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD |