FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3051191
·
Received April 10, 2013
Report
- Report Number
- 2182208-2013-01060
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 1, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, NO ANOMALIES WERE FOUND, NO CORRECTION REQUIRED.
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE RF HEAD WAS RETURNED FOR REPAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER HAS INTERMITTENT INTERROGATION ISSUES. THE COMPANY REPRESENTATIVE HAD REPLACED THE RADIO FREQUENCY (RF) HEAD AND THE ISSUE WAS RESOLVED. THE PROGRAMMER WAS RESTORED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DATE IS MONTH AND YEAR SPECIFIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151867 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |