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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC. UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3251-40
Device Problem Over-Sensing (1438)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2018
Event Type  malfunction  
Event Description
During an unrelated procedure, there was a crosstalk signal noted on the right ventricular channel.Device reprogramming is anticipated and the device was in stable condition.
 
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Brand Name
UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8197392
MDR Text Key131476779
Report Number2938836-2018-13285
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Model NumberCD3251-40
Device Lot Number6510420
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2018
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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