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

Model Number 24970A

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

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

Event Date 05/14/2019

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 user had noted several issues while using the mobile programmer and its affiliated application.The battery on the user's tablet was draining too fast, about 1% per minute and it was speculated that it could be due to the variable gain amplifier (vga) slave cable.It was additionally noted that when plugged in the tablet does not charge and at a battery level of 23% the tablet tells the user it must be plugged in and continues to generate the error message.It was also noted that even in airplane mode it was not charging sufficiently.It was further reported that clearing analyzer measurements crashes the application and that there are connectivity issues with the implantable heart device, that it loses connectivity several times per [implant procedure] case and that the user experienced one incident of being unable to re-establish the connection without a reset.Finally it was reported that reports generate slowly.The mobile programmer and the application remain in use.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK SMARTSYNC BASE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8670861
• MDR Text Key: 147071009
• Report Number: 2182208-2019-01026
• Device Sequence Number: 1
• Product Code: DTC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• 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