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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3365-40Q
Device Problem Migration (4003)
Patient Problems Twiddlers Syndrome (2114); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
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: 2017865-2020-23660, 2017865-2020-23661.It was reported the patient had been twiddling their implantable cardioverter defibrillator.They presented for a revision procedure where a fluoroscopy was completed to reveal the left ventricular lead was dislodged, and the lead impedance was > 2000 ohms.Upon pre-operation interrogation, the right ventricular lead had a capture threshold increase and an increase in impedance.Upon examination, it was observed the lead had lost lead slack as a result of the twiddlers.The two leads were explanted and replaced.During extraction, the atrial lead was damaged from the laser method, so the physician elected to explant the entire system and downgrade the device.There was also a vascular dissection during the removal and how it was resolved was unknown.The patient was stable following the procedure.
 
Event Description
New information received indicated the dissection was not serious enough for surgical intervention.The patient was stable and discharged after the procedure.
 
Manufacturer Narrative
Analysis was normal.No device problems found.
 
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Brand Name
QUADRA ASSURA CRT-D QUAD 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 Key11078068
MDR Text Key223797567
Report Number2017865-2020-23657
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508292
UDI-Public05414734508292
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,Followup,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Model NumberCD3365-40Q
Device Catalogue NumberCD3365-40Q
Device Lot NumberA000003321
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR.; QUARTET.; OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; QUARTET
Patient Outcome(s) Other; Required Intervention;
Patient Age81 YR
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