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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL ELLIPSE VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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ABBOTT MEDICAL ELLIPSE VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number CD1377-36QC
Device Problems Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
Event Type  Injury  
Event Description
I am writing about an urgent concern on a ellipse device that was implanted on me 4 days ago, according to the fda inform on medical devices recalls my icd reference was supposedly recalled.The device not only matches the recalled model but the manufacturing and distribution dates as well.My device reference is ellipse vr cd1377-36qc.The main reason for the recall was the device inability to deliver proper high voltage therapies.Currently i am having serious risk of sudden cardiac death, and i want you to give some insight in order to contact abott so that maybe they could help me understand the reason why i was implanted a recalled and useless device one year after a recall event occurred.Manufactured 04/19/2019.Fda safety report id #(b)(4).
 
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Brand Name
ELLIPSE VR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
ABBOTT MEDICAL
MDR Report Key10373055
MDR Text Key202055387
Report NumberMW5095915
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/30/2021
Device Model NumberCD1377-36QC
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age24 YR
Patient Weight92
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