FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4161020
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02760
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 28, 2014
- Report Date
- July 28, 2014
- 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
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 CUSTOMER COMMENT THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE AND THEREFORE THE LINK ELECTRONIC MODULE (LEM) BOARD WAS REPLACED AND CALIBRATED. IT WAS FURTHER REPORTED THAT THE UPPER HINGE PLATE WAS CRACKED AND IT WAS REPLACED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE IMPLANTABLE HEART DEVICES. MULTIPLE NORMALLY FUNCTIONING RADIOFREQUENCY PROGRAMMER HEADS WERE USED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642521 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 229047 SOFTWARE ANALYZER |