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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 Display or Visual Feedback Problem (1184); Data Problem (3196)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
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 an implant procedure, the right atrial (ra) lead and right ventricular (rv) lead measurements were acceptable, however when the left ventricular (lv) lead was tested there was no capture. The user went back to the programmed settings and noted the lv parameter section looked empty and it appeared that the lv was not programmed on. The lv was programmed to bi-ventricular (bi-v) and lv; when lv capture was attempted again, there was no capture. It was noted that a diagnostic message appeared indicating the presence of undesirable interaction. When a different programmer model was used, the programmed nominal settings were reviewed and the lv threshold measured without any issue. It was noted that prior to implant the user had everything programmed correctly to nominal settings. No patient complications have been reported as a result of this event.

 
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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 Key10176462
MDR Text Key196226953
Report Number2182208-2020-01131
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
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

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