FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3990963
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02201
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Report Date
- June 10, 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
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE WAS NOT ABLE TO INTERROGATE IMPLANTABLE DEVICES AND FAILED UPLINK FUNCTIONAL TESTS DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. AS A RESULT THE CABLE WAS REPLACED. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469865 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |