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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3357-40C
Device Problems Over-Sensing (1438); Capturing Problem (2891)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 06/07/2018
Event Type  malfunction  
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
It was reported that on the way to the hospital, in the ambulance, external pacing was required.It was noted that the device performed normally once the patient arrived at the hospital.Episodes of non-sustained right ventricular oversensing were noted on the implantable cardioverter defibrillator.It was suspected that the oversensing was due to lead dislodgement or far p-wave oversensing.The patient was not well but was not reported to be symptomatic due to the oversensing.No additional information was reported.
 
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Brand Name
UNIFY ASSURA CRT-D RF HV
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7668085
MDR Text Key113389003
Report Number2017865-2018-09884
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508186
UDI-Public05414734508186
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Model NumberCD3357-40C
Device Catalogue NumberCD3357-40C
Device Lot NumberA000021408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
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