FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2955644
·
Received February 11, 2013
Report
- Report Number
- 2182208-2013-00374
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- December 13, 2012
- 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
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. ANALYSIS FOUND THAT THE CABLE WAS DAMAGED AND THE LABEL WAS MISSING ITS BACKING. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER IS NOT BOOTING UP CONSISTENTLY. IT WAS ALSO REPORTED THERE IS EKG (ELECTROCARDIOGRAM) NOISE FROM THE CONNECTION. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58442 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090 PROGRAMMER, 2290 ANALYZER |