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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3267-40Q
Device Problem Delayed Charge Time (2586)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.There was no battery performance alert that was triggered.Estimated battery longevity was 5 months remaining.Device having been implanted since (b)(6) 2013 for ~7.5 years.
 
Event Description
It was reported that although previous reports of the battery appeared to be tracking normally, the charge time had been extending with each transmission over the past two years.The device was pending explant for prolonged charge time.The patient was stable.
 
Event Description
New information received notes the device was explanted and replaced.The patient was stable throughout.
 
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Brand Name
QUADRA ASSURA DDQP+
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11753476
MDR Text Key248213080
Report Number2017865-2021-16998
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 05/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2015
Device Model NumberCD3267-40Q
Device Lot Number4250821
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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