FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2790178
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03429
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P890003/S145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT CONFIRM THE CRACKING SOUND, HOWEVER THE POWER SUPPLY HAD A BURNT SMELL, WHICH WAS LIKELY THE CAUSE OF THE CRACKING SOUND. IT WAS ALSO NOTED THAT THE LIGHT-EMITTING DIODE (LED) CONTROL OUTPUT WAS OUT OF SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CRACKING SOUND WAS HEARD FROM THE BACK OF THE PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PROGRAMMER | NVZ | MEDTRONIC, INC. | 2090X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 2290 PACING SYSTEM ANALYZER |