FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3151768
·
Received June 7, 2013
Report
- Report Number
- 2182208-2013-01261
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- December 17, 2012
- Report Date
- March 1, 2013
- Manufacturer
- RICE CREEK MANUFACTURING
- 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
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE RADIO FREQUENCY PROGRAMMER HEAD WAS RETURNED AND ANALYSIS FOUND THAT THE CABLE WAS CUT WHICH WOULD NOT ALLOW IT TO INTERROGATE. (B)(4).
Description of Event or Problem · 1
THE RADIO FREQUENCY HEAD WAS RETURNED WITH NO INFORMATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253037 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MANUFACTURING | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |