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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC. (CRM-KISTA) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3361-40
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
Event Type  Injury  
Event Description
It was reported that a telemetry anomaly was observed during a follow up.Both wand and antenna were used and resulted in the same slow interrogation.The device was explanted and replaced.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Analysis was normal.No anomaly was found.
 
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Brand Name
UNIFY ASSURA ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
ulla strindlund
box 7051
isafjordsgatan 15
kista SE-16-407
SW   SE-16407
4684744043
MDR Report Key4903247
MDR Text Key18885755
Report Number3010215456-2015-27959
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2015
Device Model NumberCD3361-40
Device Lot Number4355224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2013
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 Outcome(s) Required Intervention;
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