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

Model Number D00U002

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Communication or Transmission Problem (2896)

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

Event Date 10/20/2017

Event Type  malfunction  

Event Description

It was reported that, prior to lead analysis, the mobile programmer application displayed a dotted line on the electrocardiogram (ecg) readout.It was noted that this behavior occurred in the presence of electro-cautery.The user was advised to avoid direct contact of the mobile programmer base with a metal surface, in the presence of electro-cautery.It was further reported that, upon the initiation of pacing, the application displayed the message ¿loss of communication, application has lost communication with analyzer.¿ while troubleshooting the issue, the battery replacement indication appeared and could not be cleared.The lead analysis was completed using a legacy programmer/analyzer.Following the procedure, the user performed additional troubleshooting and reported the application displaying an electrical reset warning.The application was uninstalled and re-installed on the mobile device.It was noted that the aforementioned issues did not recur in a subsequent procedure, following this action.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: 7101642
• MDR Text Key: 94553381
• Report Number: 2182208-2017-02173
• 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: Other
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• 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
• Date Manufacturer Received: 10/20/2017
• 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