FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 4161247
·
Received October 10, 2014
Report
- Report Number
- 2182208-2014-02727
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 18, 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 REPORTED INTERROGATION ISSUE; RF (RADIO FREQUENCY) HEAD FOUND OUT OF SPECIFICATION ON UPLINK FUNCTIONAL TESTS. RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RF HEAD LABEL BACK COATING IS MISSING. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROGRAMMER HEAD WOULD NOT INTERROGATE DEVICES; NO GREEN LIGHTS WHEN PLACED OVER A DEVICE. THE PROGRAMMER HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638861 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090W PROGRAMMER |