FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2131561
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00980
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S080
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE ECG CONNECTOR IS LOOSE.
Description of Event or Problem · 1
IT WAS REPORTED THE KEYBOARD WAS BROKEN AND THE TOUCH PEN DIDN'T WORK WELL, EVEN WHEN IT WAS NEW. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK PROGRAM W/TELEMETRY C | PROGRAMMER | DXY | MEDTRONIC, INC. | 2090W | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2290 PACING SYSTEM ANALYZER| 2067L PROGRAMMER RF HEAD |