CARELINK
Report
- Report Number
- 2182208-2014-02244
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 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
(B)(6). (B)(4).
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT OF A SMASHED SCREEN AND DAMAGED POWER CORD CABLE (DAMAGED AT CONNECTOR END AND INSULATED WIRES ARE VISIBLE) AND THEREFORE THE BEZEL OVERLAY ASSEMBLY WAS REPLACED, THE STYLUS CALIBRATED AND THE POWER CORD CABLE WAS REPLACED AS WELL. ANALYSIS ALSO FOUND THAT BOTH KEYBOARD HINGES WERE BROKEN AND THE POWER CORD BAY WAS CORRODED, ALL WERE REPLACED. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PROGRAMMER HAD A SMASHED SCREEN AND THAT THE POWER CORD REQUIRED REPLACEMENT. FOLLOW-UP DETERMINED THAT THIS WAS DUE TO FRAYED WIRES IN THE CORD. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PROGRAMMER HAD A SMASHED SCREEN AND THAT THE POWER CORD REQUIRED REPLACEMENT. FOLLOW-UP DETERMINED THAT THIS WAS DUE TO FRAYED WIRES IN THE CORD. THE PROGRAMMER WAS 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 |
|---|---|---|---|---|---|---|---|
| 468447 | CARELINK | PROGRAMMER, PACEMAKER | KRG | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |