MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number D00U002

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

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

Event Date 02/01/2018

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 mobile programmer application crashed and bluetooth connection was lost, when the mobile device went into sleep mode after an extended idle period. It was noted that this occurred during patient venous access, prior to application use. It was further reported that the application exhibited slow response times when switching between screens. It was noted that lead analysis was able to be completed in a timely manner, despite these issues. The application remains in use. No patient complications have been reported as a result of this event.

• Brand Name: CARELINK SMARTSYNC
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• 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: 7418907
• MDR Text Key: 105261792
• Report Number: 2182208-2018-00600
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K163008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/10/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/10/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: D00U002
• Device Catalogue Number: D00U002
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse