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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3361-40QC
Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Event Description
It was reported that a patient presented for an unrelated procedure.During the procedure, the set screw of the patient's implantable cardioverter defibrillator could not be tightened, and the device header would not release the left ventricular lead.Physician replaced the device on (b)(6) 2021.The patient was discharged.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
UNIFY ASSURA ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11748236
MDR Text Key248041523
Report Number2017865-2021-16780
Device Sequence Number1
Product Code NIK
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,foreig
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model NumberCD3361-40QC
Device Lot NumberP000109722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/11/2021
Initial Date FDA Received04/29/2021
Supplement Dates Manufacturer Received05/19/2021
Supplement Dates FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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