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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. CARELINK SMARTSYNC PLATFORM (IOS) ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
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.

 
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Brand NameCARELINK SMARTSYNC PLATFORM (IOS)
Type of DeviceANALYZER, 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 Key10041998
MDR Text Key190515127
Report Number2182208-2020-00884
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM01A01
Device Catalogue NumberM01A01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
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

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