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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3369-40Q
Device Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problems Fainting (1847); Dizziness (2194)
Event Date 02/28/2017
Event Type  Injury  
Event Description
It was reported that during follow-up in clinic, non-sustained rv oversensing was observed on the right ventricular channel.Failure to pace was also noted due to noise.Patient reported presyncope and dizziness.Programming changes were recommended.No further information was provided.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6527175
MDR Text Key73865093
Report Number2938836-2017-22912
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Model NumberCD3369-40Q
Device Lot NumberA000023944
Other Device ID Number05414734508377
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age81 YR
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