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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 Operating System Problem (2898); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 07/28/2020
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 programmer software on the tablet froze and became unresponsive, after saving a final report and choosing to share the file. The issue occurred on multiple occasions and sometimes displayed a white screen. To resolve the issue the application required a shut down and restart which in turn wiped all testing data. The programmer remains in use. 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 Key10400955
MDR Text Key202701495
Report Number2182208-2020-01507
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 08/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2020
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 Received07/28/2020
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

Patient TREATMENT DATA
Date Received: 08/13/2020 Patient Sequence Number: 1
Treatment
PROGRAMMER 24970A
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