FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3152954
·
Received June 8, 2013
Report
- Report Number
- 2183613-2013-00585
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- MEDTRONIC MILACA, INC.
- 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED PROGRAMMER RF (RADIO-FREQUENCY) HEAD TELEMETRY ISSUES. IT WOULD NOT INTERROGATE CONSISTENTLY DUE TO THE CABLE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD FAILED TO INITIATE TELEMETRY WITH A DEVICE THAT WAS STILL IN ITS STERILE PACKAGING. ATTEMPTS TO INTERROGATE OTHER DEVICES WERE ALSO UNSUCCESSFUL. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256201 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC MILACA, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090 PROGRAMMER |