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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; No Match
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ABBOTT QUADRA ASSURA MP ICD; No Match Back to Search Results
Model Number CD3371-40C
Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2024
Event Type  malfunction  
Event Description
During implant to upgrade the patient to a crt-d device, the leads were connected to the new device but a loss of capture, high pacing impedance and loss of sensing were observed.The leads were measured with a psa and returned normal measurements.The event was resolved by explanting and replacing the device.The patient was in stable condition.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19088431
MDR Text Key339926457
Report Number2017865-2024-38189
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508384
UDI-Public(01)05414734508384(10)A000147880(17)250831
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCD3371-40C
Device Lot NumberA000147880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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