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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

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ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problems Break (1069); Failure to Capture (1081); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that loss of capture was noted on the left ventricular (lv) lead.Lv lead damage was observed.The lv lead was partially explanted, capped and replaced during an unrelated procedure to resolve the event.The patient was in stable condition.
 
Event Description
Additional information was received indicating the left ventricular (lv) lead damage observed was lead fracture.
 
Manufacturer Narrative
The reported events of loss of capture and lead fracture were confirmed.As received, a partial lead (connector portion) was returned in one piece.Visual and x-ray examinations of the lead found that all the inner coil filars were fractured at the middle region of the lead.The lead was bent in this location.The cause of the reported event of loss of capture was isolated to the inner coil fracture.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
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 Key16443431
MDR Text Key310260703
Report Number2017865-2023-10962
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)Y
Reporter Country CodeSP
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,Followup
Report Date 04/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2016
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot Number4267128
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2013
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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