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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 CD3265-40Q
Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
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
It was reported that a patient presented with their implantable cardioverter defibrillator (icd) that was in backup operation.The device was reprogrammed back to normal settings.The patient was stable.
 
Event Description
New information notes that the system exhibited a false battery performance alert (bpa) due to the reset.
 
Event Description
New information notes that due to the issue, the field was unable to obtain battery data and longevity estimates through direct interrogations.
 
Event Description
New information notes that the device was explanted due to the issues.The patient was stable.
 
Manufacturer Narrative
The reported field event of bpa was verified in the lab.However, further investigation showed the bpa was a false positive.Prior to the event, device had a reset, which cleared the device¿s usage data.The bpa algorithm uses device usage history data for calculations, and since that data got cleared after reset, a false bpa was triggered.This is normal and expected behavior when the data is cleared, and the device had been implanted for more than 6 years.Interrogation of the device revealed the device was above eri when received.No other anomaly was detected.The reported event or reset could not be confirmed.The device was not in backup operating mode upon receipt, additionally, a device image was not saved at the time of reset; the cause of reset could not be determined.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.
 
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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 Key10660193
MDR Text Key211050090
Report Number2017865-2020-15211
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734505673
UDI-Public05414734505673
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,Followup
Report Date 04/04/2021
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 Date04/30/2015
Device Model NumberCD3265-40Q
Device Catalogue NumberCD3265-40Q
Device Lot Number4285344
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/11/2020
Supplement Dates Manufacturer Received10/07/2020
10/21/2020
02/22/2021
03/11/2021
Supplement Dates FDA Received10/18/2020
11/09/2020
03/04/2021
04/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight84
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