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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 Problem Computer Operating System Problem (2898)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
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 diagnostic mobile programmer application froze during a session.The user had to close it and re-open it in order for it to work again.The application required a software update.The device remains in use.There was no patient complications reported with this event.
 
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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 Key10188084
MDR Text Key196225826
Report Number2182208-2020-01157
Device Sequence Number1
Product Code DTC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
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
Date Manufacturer Received05/26/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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