FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4161051
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02752
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 23, 2014
- Report Date
- July 23, 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 RF (RADIO FREQUENCY) HEAD WAS NOT ABLE TO INTERROGATE AND THE RF HEAD CABLE WAS TWISTED; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RF (RADIO FREQUENCY) HEAD HAS BEEN HAVING COMMUNICATION ISSUES WITH DEVICES. THE RF HEAD WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642467 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090 PROGRAMMER |