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

Model Number 2090

Device Problems Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis summary: analysis was able to confirm the customer comment that the touchscreen was out of calibration and additionally noted that after the calibration the programmer started with an error which indicated that the micro processing unit (mpu) board needed to be replaced and that the bezel had minor damage but that it was considered acceptable.The mpu board was replaced, a power cord was added, the touch screen was calibrated, new software was installed, the device was cleaned and it then passed its electrical safety as well as all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer's stylus is not calibrated and its tip is not aligning with the cursor on the screen.It was further reported that it was being sent in for an upgrade and to ensure it passes its safety, functional and system testing and to replace its missing power cord.The programmer has not been received into service.There was no patient involvement.It was further reported that the product had been returned to service.

• 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: 7459937
• MDR Text Key: 106651766
• Report Number: 2182208-2018-00678
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

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: 03/06/2018
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2011
• 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