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

Model Number 2090W

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the customer comment of any issue launching the analyzer on the programmer and a crash was not confirmed.However an intermittent loss of communication between programmer and the analyzer was observed one time during systems testing.The connection was checked; there were no findings and the error could not be reproduced.The analyzer bay was replaced as as preventative.The customer comment of keyboard damage was confirmed and it was replaced.It was also noted that system fan was noisy, left keyboard hinge was broken, keyboard rail covers were cracked and broken, printer keypad had a worn button, stylus tip was pulling apart but functional.All found defective parts were replaced and all issues detected were resolved.The programmer then passed all final functional and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to procedures when the programmer was turned on and the analyzer launch was clicked, it crashed and the analyzer was not then used.It was noted that the programmer attempted to open the analyzer and then would not open and close the software.It was further reported that the programmer was damaged and that the keyboard was broken.There was no patient involvement.

• 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: 12023818
• MDR Text Key: 257770422
• Report Number: 2182208-2021-02483
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00885074301440
• UDI-Public: 00885074301440
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2021

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: 05/26/2021
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2005
• 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