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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC., CRMD UNIFY CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40Q
Device Problems Failure to Interrogate (1332); No Device Output (1435)
Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130)
Event Date 06/27/2014
Event Type  Death  
Event Description
It was reported that the patient fell and went into cardiac arrest.Paramedics arrived 14 minutes later and discovered that the patient was in vf and delivered two external defibrillation therapies.Patient had electrical activity but no pulse.Cpr was performed for 40 minutes.The patients rate later stabilized at 90 bpm but a ct scan appeared to show no brain activity.No device image could be obtained and the device exhibited no telemetry.Damage due to external defib was suspected.Device explant was recommended, but the physician wanted to wait until the patient stabilized.It was later reported that the patient expired.The patient had experienced further vf episodes and bradycardia with no resultant device based therapy evident.
 
Manufacturer Narrative
Device evaluation anticipated, but not yet begun.
 
Manufacturer Narrative
The reported inability to communicate was confirmed in the laboratory and was due to premature battery depletion.Based on all available parameter and usage information, device longevity was found to be below the expected limits.With an external power supply attached, the device functioned normally.No high current was detected during testing and the power consumption was normal.The original battery was returned to the vendor for further evaluation and analysis could not conclusively determine a root cause for the premature battery depletion.
 
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Brand Name
UNIFY 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
cary lawler
645 almanor avenue
sunnyvale, CA 94085
8184932621
MDR Report Key3953163
MDR Text Key4645757
Report Number2938836-2014-13599
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Model NumberCD3231-40Q
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/27/2014
Initial Date FDA Received07/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/10/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2011
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) Death;
Patient Age80 YR
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