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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 Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588)
Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)
Event Date 11/15/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 2017865-2020-21626; 2017865-2020-21627; 2017865-2020-21628.It was reported that patient presented to a follow-up in-clinic on (b)(6) 2020 with multiple inappropriate shocks.Further investigation found that all three leads, atrial, right ventricular, and left ventricular, were exhibiting noise and high out of range pacing impedance.The implantable cardioverter defibrillator (icd) was also reported as having noise over-sensing.It is unclear as to whether the issue is a lead issue, or an icd header issue.Only the device was explanted and replaced on (b)(6) 2020.It was still unclear as to if the noise, shocks, and high impedance values were a device or lead issue.Patient was stable after the procedure.
 
Manufacturer Narrative
Final analysis found a hybrid capacitor connection anomaly which resulted in out of range impedance measurements and noise.
 
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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 Key10939105
MDR Text Key219287906
Report Number2017865-2020-21625
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,health
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Model NumberCD3369-40Q
Device Catalogue NumberCD3369-40Q
Device Lot NumberA000048694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/15/2020
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer Received02/11/2021
Supplement Dates FDA Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DURATA LEAD; QUARTET LEAD; TENDRIL STS LEAD; DURATA LEAD; QUARTET LEAD; TENDRIL STS LEAD
Patient Outcome(s) Required Intervention;
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