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U.S. Department of Health and Human Services

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

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ABBOTT QUICKFLEX XL LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1158T/86
Device Problems Break (1069); High impedance (1291); High Capture Threshold (3266)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2020
Event Type  malfunction  
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.
 
Event Description
The patient presented in-clinic following a vibratory alert from the device.The device was interrogated and it was revealed that the pacing impedance of the left ventricular (lv) lead was high and out-of-range.It was also observed that the capture threshold has increased on the lv lead.It was suspected that the cause of the event was due to damage to the ring electrode of the lv lead; however, no imaging was conducted to confirm the supposition.The device was reprogrammed to resolve the event.The patient was stable with no consequences.
 
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Brand Name
QUICKFLEX XL 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 Key10547840
MDR Text Key207360829
Report Number2017865-2020-13539
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 09/17/2020
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 Date02/28/2014
Device Model Number1158T/86
Device Lot Number3324694
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2011
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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