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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3369-40Q
Device Problem Delayed Charge Time (2586)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that while preparing the implantable cardioverter defibrillator prior to implant procedure, upon interrogation it was noted that the device exhibited delayed charge time.The device was not used.There was no patient involvement.
 
Manufacturer Narrative
The reported event of long charge time was confirmed via review of the device image but could not be replicated in the laboratory.High voltage charging was performed in the laboratory, and the charge time was within specifications.The device¿s high voltage capacitors were analyzed by its manufacturer and no anomalies were found.
 
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Brand Name
QUADRA ASSURA MP 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 Key9931526
MDR Text Key186684149
Report Number2017865-2020-04023
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508377
UDI-Public05414734508377
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,user f
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberCD3369-40Q
Device Catalogue NumberCD3369-40Q
Device Lot NumberA000092579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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