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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number D00U002
Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that there was an application crash during the threshold test. The screen froze. After 10 seconds, the lead cable to stop pacing was removed and connected to the legacy programmer/analyzer to complete the lead analysis. After testing, use of the mobile programmer application was again attempted, but it was still frozen. When selecting threshold again, an error message occurred. It was further noted that a threshold test during lead analysis, performed using the mobile programmer application/pacing system analyzer, was unacceptable in its responsiveness. The mobile programmer application remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameCARELINK SMARTSYNC
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7102825
MDR Text Key94539923
Report Number2182208-2017-02197
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK163008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberD00U002
Device Catalogue NumberD00U002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
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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