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

Model Number 2090W

Device Problems Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996); Output Problem (3005); Problem with Software Installation (3013)

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

Event Date 05/04/2018

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 crashed during a software upload with a memory stick.It also generated a printer failure message for both internal and external printers during the software upload attempt.The next day the programmer was connected to the software distribution network but it was unable to load and the same printer error persisted.It was also noted that the power cord was "bad." the programmer was returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis confirmed the customer comment of "crash"during update attempt and print issue, noting that the drive was full and the software was reconfigured, reloaded and updated.Analysis also confirmed that the power cord had a loose connector and the power cord was therefore replaced.It was additionally noted that both antenna cables were damaged, the power cord bay latches were broken, the electrocardiogram connector was loose and the upper hinge, keyboard latch and the power cord bay were broken.Inspected electrical circuit boards and mechanical parts.All salvage material was inspected to meet all applicable criteria and the device passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

• 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: 7504752
• MDR Text Key: 107967222
• Report Number: 2182208-2018-00890
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

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: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2006
• 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