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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 CD3357-40Q
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
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
Related manufacturer reference number: 2017865-2020-16083.It was reported the left ventricular lead was capped on (b)(6) 2020 due to lead dislodgement and the implantable cardioverter was also explanted for unknown reasons.How the issue was discovered was unknown.The patient symptoms and current condition were unknown.
 
Event Description
New information revealed the implantable cardioverter defibrillator was explanted electively and there was no allegation of malfunction on the device.
 
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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
MDR Report Key10731321
MDR Text Key212965082
Report Number2017865-2020-16085
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508216
UDI-Public05414734508216
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model NumberCD3357-40Q
Device Catalogue NumberCD3357-40Q
Device Lot NumberA000065538
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
QUICKFLEX MICRO LV LEAD
Patient Outcome(s) Required Intervention;
Patient Age82 YR
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