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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL BIVENTRICULAR DEFIBRILLATOR ST. JUDE MEDICAL; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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ST. JUDE MEDICAL / ABBOTT MEDICAL BIVENTRICULAR DEFIBRILLATOR ST. JUDE MEDICAL; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number CD3369-40Q
Device Problems Over-Sensing (1438); Application Program Problem (2880)
Patient Problems Atrial Fibrillation (1729); Heart Block (4444)
Event Date 05/07/2021
Event Type  Injury  
Event Description
Patient has severe heart failure and is post lvad placement (b)(6) 2021 with multiple complications.She underwent cardioversion for atrial fibrillation (b)(6) 2021 complicated by st.Jude/abbot biventricular icd malfunction.This included oversensing that inhibited pacing (patient was in complete heart block), and inability to program the generator to voo settings.We were able to program voo mode in the mri mode tab (but overnight, this reverted to a sensing mode).The patient underwent icd generator replacement, at which point oversensing continued to be noted.On fluoroscopy, the rv icd lead tip was found to be very close to the lvad position.A new rv icd lead was placed with resolution of both sensing and programming issues.Fda safety report id # (b)(4).
 
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Brand Name
BIVENTRICULAR DEFIBRILLATOR ST. JUDE MEDICAL
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
ST. JUDE MEDICAL / ABBOTT MEDICAL
MDR Report Key12032099
MDR Text Key257415425
Report NumberMW5101967
Device Sequence Number1
Product Code NIK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 06/15/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCD3369-40Q
Device Catalogue NumberCD3369-40Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/17/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight75
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