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

Model Number M01A01

Device Problems Computer Software Problem (1112); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis of available software application data was conducted and was unable to establish the root cause of the event described in the customer comment.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the mobile programmer application crashed on start up with a 'fatal error' message.A restart was attempted with no results.The issue began when the hosting tablet was updated after not being used for a while.There was no mobile programmer base assigned to this tablet.There was no patient involvement.

• Brand Name: CARELINK SMARTSYNC PLATFORM (IOS)
• 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: 10041998
• MDR Text Key: 190515127
• Report Number: 2182208-2020-00884
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M01A01
• Device Catalogue Number: M01A01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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