FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3990355
·
Received August 7, 2014
Report
- Report Number
- 2182208-2014-02253
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- April 30, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE RF (RADIO FREQUENCY) HEAD FAILED ELECTROMAGNETIC FIELD IMMUNITY FUNCTIONAL; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RF HEAD LABEL IS DELAMINATED (RUBBER PORTION OF LABEL IS MISSING). (B)(4).
Description of Event or Problem · 1
THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463639 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090AM PROGRAMMER |