MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problems Contamination (1120); No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis confirmed the reason for return, a component on the display was defective.It was also noted that the floppy drive was corroded, the bezel had minor damage, the right hinge was broken, the left hinge was worn, the keyboard was broken, the lower bullets were worn, the medtronic logo button was missing, the lower case was missing all four rubber feet, and the link electronic module (lem) circuit board was corroded.As a result the display component, floppy drive, hinges, keyboard, lower bullets, logo button and lower case were replaced.The lem board was replaced as a preventive action.The programmer then passed all final functional and systems tests.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer display remained blank with the backlight on and nothing came on the screen.The programmer was returned for servicing.During service and repair it was noted that there was corrosion on a circuit board.There was no patient involvement.

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6469702
• MDR Text Key: 72201311
• Report Number: 2182208-2017-00603
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1