FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2952514
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00182
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 21, 2012
- Report Date
- November 21, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE RF (RADIO FREQUENCY) HEAD CABLE IS FRAYED. IT IS NOTED THE RF HEAD HAD NORMAL TELEMETRY AND PASSED FUNCTIONAL TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THE CORD ON THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS FRAYED. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55635 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |