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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL FORTIFY VR 1231-40Q ICD 7004948; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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ST. JUDE MEDICAL / ABBOTT MEDICAL FORTIFY VR 1231-40Q ICD 7004948; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number MERLIN PCS 30694 3330 V24.5.1
Device Problem Defibrillation/Stimulation Problem (1573)
Patient Problems Chest Pain (1776); Muscle Weakness (1967)
Event Date 08/01/2019
Event Type  Death  
Event Description
My husband had an icd installed back in 2013 for heart rhythm problems.He seemed to do well and it never fired but the last two years before he died he was in and out of hospitals for chest pain, weakness, and low to high range heart rhythm.He went to various hospitals including the one that installed the device, but no one seemed to be able to tell me what was going on.I was his poa for health care and also through (b)(6).I did receive a letter stating there was a problem with the batteries in some of the devices, and i brought it to the (b)(6) but they assured me it wasn't his.I can't help but wonder, why didn't it fire if he was in heart failure? i have some of the reports that the (b)(6) was monitoring the device and i had the in home monitor but i believe that went to the company.Fda safety report id # (b)(4).
 
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Brand Name
FORTIFY VR 1231-40Q ICD 7004948
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
ST. JUDE MEDICAL / ABBOTT MEDICAL
MDR Report Key12318299
MDR Text Key266622801
Report NumberMW5103220
Device Sequence Number1
Product Code NIK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMERLIN PCS 30694 3330 V24.5.1
Device Catalogue Number7004948 PRC.D.9E
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening;
Patient Age75 YR
Patient Weight64
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