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

Model Number 2090W

Device Problems Computer Software Problem (1112); No Display/Image (1183); Mechanical Problem (1384); Loss of Power (1475); Operating System Becomes Nonfunctional (2996); Unexpected Shutdown (4019)

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

Event Date 07/10/2018

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 got the "blue screen of death" and the programmer "died" after that.The back door also needs attention.The programmer was returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis was unable to confirm the customer comments, the programmer powered up and interrogated multiple times with no issues and there were no errors found in the event logs.The hard drive was reconfigured and the software reloaded as a preventive.It was confirmed that the power cord bay door was broken and it was therefore replaced.The programmer passed functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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: 7747695
• MDR Text Key: 116378371
• Report Number: 2182208-2018-01416
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994127631
• UDI-Public: 00613994127631
• 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,Followup,Followup
• Report Date: 10/03/2018

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: 07/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/03/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/08/2018; 10/02/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2004
• 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