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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ELLIPSE DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT ELLIPSE DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2377-36QC
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2023
Event Type  malfunction  
Event Description
It was reported that during a remote follow up, inadequate morphology templates were noted on the device.Abbott technical support was contacted and reprogramming of the device was recommended.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.
 
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Brand Name
ELLIPSE DR ICD, US
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16753809
MDR Text Key313434430
Report Number2017865-2023-17756
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P910023
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
Report Date 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCD2377-36QC
Device Lot NumberA000127451
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2022
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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