CARELINK
Report
- Report Number
- 2182208-2013-01551
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 2013
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF TELEMETRY FAILURE, THE PROGRAMMER HEAD PASSED FUNCTIONAL AND SYSTEMS TESTS AND NO OTHER ANOMALIES WERE FOUND. 2090: ANALYSIS CONFIRMED THE CUSTOMER COMMENT OF TELEMETRY FAILURE AND ATTRIBUTED IT TO THE PRINTED CIRCUIT (PC) LINK ELECTRONIC MODULE (LEM) BOARD WHICH WAS THEREFORE REPLACED. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PROGRAMMER HAD "TELEMETRY FAILURE." BOTH THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PROGRAMMER HAD "TELEMETRY FAILURE." BOTH THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253068 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |