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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); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
During a remote follow-up, increased pacing impedance and increased capture were detected on the left ventricular (lv) lead.The device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.
 
Event Description
Additional information was received that there is suspected lead damage, although not confirmed, and extra cardiac stimulation that was previously observed.
 
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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 Key19037161
MDR Text Key339297984
Report Number2017865-2024-37586
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public(01)05414734503198(10)4888899(17)171130
Combination Product (y/n)Y
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Model Number1458Q/86
Device Lot Number4888899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/20/2014
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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