FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2131489
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00962
- 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE PROGRAMMER POWERED UP WITH A SYSTEM ERROR. PRINTED CIRCUIT BOARD FOUND OUT OF SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE POWER SUPPLY WAS ON, THREE SHORT BEEPS OCCURRED REPEATEDLY, AND THE PROGRAMMER COULD NOT OPERATE. 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 |