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

Model Number 2090W

Device Problems Component Missing (2306); Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer screen calibration failed.It was noted that the universal serial bus (usb) port failed and the case had a missing plastic part.The status of the programmer is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the stylus cursor jumps over some lines on the touch screen, however, analysis was unable to confirm the universal serial bus (usb) issue.It was noted that the link electronic module (lem) board component failed-cause unknown, the keyboard left and right hinges were broken, case left and right slide rails were broken, the cord bay cover was broken, hinge cover bullets were missing, and the handle was broken.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional and system tests.

Event Description

It was further reported that the programmer was returned.

• Brand Name: CARELINK PROGRAMMER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9901823
• MDR Text Key: 187205918
• Report Number: 2182208-2020-00620
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

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: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2020
• Initial Date Manufacturer Received: 03/22/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2005
• 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