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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH
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ABBOTT QUARTET; NO MATCH Back to Search Results
Model Number 1458Q/86
Device Problems Break (1069); Failure to Capture (1081); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Event Description
During follow-up, increased pacing impedance and loss of capture was observed on the left ventricular lead.Lead damage was suspected, although not confirmed.The event was resolved by reprogramming the device.The patient was in stable condition.
 
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Brand Name
QUARTET
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 Key18387168
MDR Text Key331250052
Report Number2017865-2023-95483
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)Y
Reporter Country CodeIT
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,Followup
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2017
Device Model Number1458Q/86
Device Lot Number4455390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received03/08/2024
Supplement Dates FDA Received03/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2014
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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