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U.S. Department of Health and Human Services

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

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MEDTRONIC INC. CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Display or Visual Feedback Problem (1184); Pacing Problem (1439)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during use of the analyzer of the mobile programmer it was sluggish and an error was generated indicating that the application needed to be closed and that the user should contact a company representative. It was noted that when trying to do a threshold test the user could not decrement the outputs and was stuck pacing at 90 beats per minute. It was further noted that while trying to analyze the implantable device the user could not select the mode or change the rate back down from 90 beats per minute. The mobile programmer was changed out for a non-mobile programmer to use its analyzer that was present as a back up to resolve the issue. The mobile programmer remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameCARELINK SMARTSYNC BASE
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 Key10585760
MDR Text Key208506300
Report Number3004593495-2020-01130
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24970A
Device Catalogue Number24970A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/21/2018
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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