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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR

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ST. JUDE MEDICAL, INC. IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR Back to Search Results
Device Problem Wireless Communication Problem (3283)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

During a follow-up, a loss of wireless communication on the device during high voltage (hv) therapy was noted; therefore, the user was unable to deactivate the high voltage therapy. It is noted the therapies being delivered were appropriate. The patient expired in (b)(6) 2016 due to comorbidities unrelated to the device or programmer. Related manufacturer report number: 2017865-2017-32325.

 
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Type of DeviceIMPLANTABLE CARDIOVERTER-DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6893500
MDR Text Key87327672
Report Number2017865-2017-31633
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeSP
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 09/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/29/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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