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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY QUADRA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC., CRMD UNIFY QUADRA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3251-40Q
Device Problems Difficult to Interrogate (1331); Over-Sensing (1438)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2015
Event Type  malfunction  
Event Description
It was reported that telemetry was lost during capacitor maintenance charging.It was also noted that before telemetry was lost, oversensing was seen.No action has been taken at this time and follow-up has been scheduled.The patient condition is fine.
 
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Brand Name
UNIFY QUADRA CRT-D, DF-4 CONNECTOR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sharon mathew
645 almanor avenue
sunnyvale, CA 94085
4085226327
MDR Report Key4760311
MDR Text Key5782601
Report Number2938836-2015-04601
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2015
Device Model NumberCD3251-40Q
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2014
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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