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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENTRANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT ENTRANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDHFA300Q
Device Problem Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Event Description
Related manufacturer report number 2017865-2021-26452.It was noted the left ventricular (lv) lead was dislodged.An x-ray was performed and confirmed the dislodgement.During the procedure to explant and replace the lv lead, it was noted the set screw could not be loosened which resulted in the lv lead being unable to disconnect from the device.The device and lv lead were explanted and replaced to resolve the event.The patient was stable.
 
Manufacturer Narrative
The reported field event of difficulty in engaging the left ventricular setscrew was confirmed in the lab.However, the issue was found to be consistent with implant/lead revision procedure.Upon bench testing the device, the left ventricular is4 setscrew was found to have been completely backed out from its connector block as a result of unscrewing the setscrew too far.The setscrew inset was also stripped and septum debris was observed inside the setscrew hex cavity.The debris inside the setscrew cavity was removed and setscrew was re-engaged with the connector block and operated normally in affixing a test lead to the device.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.The device's functionality was bench tested; telemetry, pacing, sensing, impedance, high voltage output, high voltage shock, and patient notifier were tested on the bench.No anomaly was detected.
 
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Brand Name
ENTRANT HF
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key12205068
MDR Text Key262729959
Report Number2017865-2021-26453
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032850
UDI-Public05415067032850
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model NumberCDHFA300Q
Device Catalogue NumberCDHFA300Q
Device Lot NumberS000077808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
QUARTET LEAD SMALL-S, 86 CM; QUARTET LEAD SMALL-S, 86 CM
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