FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3991610
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02125
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 13, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE TELEMETRY FAILURE WAS CAUSED BY THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. AS A RESULT THE CABLE WAS REPLACED. IT WAS ALSO NOTED THAT THE LABEL WAS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A TELEMETRY FAILURE. THE RADIO FREQUENCY (RF HEAD) WAS EXCHANGED AND RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470874 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090 CARELINK PROGRAMMER |