CARELINK
Report
- Report Number
- 2182208-2014-01471
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 16, 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
PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE ANALYZER DISPLAYED A MESSAGE REGARDING LOSS OF COMMUNICATION WITH THE PROGRAMMER. THE ANALYZER PASSED FINAL FUNCTIONAL AND SYSTEMS TESTS AND NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCT: PRODUCT ID 2067 RADIOFREQUENCY PROGRAMMER HEAD. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 2067 RADIOFREQUENCY PROGRAMMER HEAD. (B)(4).
IT WAS REPORTED THAT THE ANALYZER CONNECTED TO THE PROGRAMMER GENERATED A MESSAGE "LOSS OF COMMUNICATION, RESTART OR END SESSION IF PROBLEM PERSISTS." BOTH THE PROGRAMMER AND THE ANALYZER WERE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE ANALYZER, WHILE CONNECTED TO THE PROGRAMMER GENERATED A MESSAGE "LOSS OF COMMUNICATION, RESTART OR END SESSION IF PROBLEM PERSISTS." BOTH THE PROGRAMMER AND THE ANALYZER 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 |
|---|---|---|---|---|---|---|---|
| 341728 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 229047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2090AA4 PROGRAMMER| 2090AA4 PROGRAMMER |