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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

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ABBOTT QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T/86
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2022
Event Type  malfunction  
Event Description
Related manufacturer report number: 2017865-2022-39901 during follow-up, increased pacing impedance was observed on the right atrial (ra) lead.During a revision procedure, ra lead damage was observed and insulation damage was observed on the left ventricular (lv) lead.The event was resolved by explanting and replacing the ra and lv leads.The patient was in stable condition.
 
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.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key15510620
MDR Text Key306083757
Report Number2017865-2022-39902
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734502610
UDI-Public05414734502610
Combination Product (y/n)Y
Reporter Country CodeGM
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 02/23/2023
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 Date08/31/2013
Device Model Number1258T/86
Device Catalogue Number1258T-86
Device Lot Number3195436
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/20/2022
Initial Date FDA Received09/30/2022
Supplement Dates Manufacturer Received02/23/2023
Supplement Dates FDA Received02/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2010
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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