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

Model Number 2090

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996); Power Problem (3010)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to confirm the reported reboot, shutdown, and black display screen issues.However, there was a system error in the logs.The programmer hard drive was reconfigured, reloaded, and had the software updated.Analysis also noted that the power cord bay was broken, the power cord bay was replaced.The programmer passed all final functional an and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was unable to complete an interrogation because the programmer would start then reboot, start and then shutdown, and unexpectedly displayed a black screen multiple times during the interrogation.The programmer was returned for service.No patient complications have been reported as a result of this event.

• 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: 7256657
• MDR Text Key: 99898842
• Report Number: 2182208-2018-00198
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994581570
• UDI-Public: 00613994581570
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

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: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• 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