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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3357-40C
Device Problem Over-Sensing (1438)
Patient Problem Syncope (1610)
Event Date 04/20/2019
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that when the dependent patient presented in emergency room, oversensing was observed on the device.The patient¿s merlin on-demand transmission was sent for evaluation after the patient experienced a syncopal episode.The following physician noted that during the recent generator chang-out, the rv lead was plugged into the lv pace/sense port.Therefore, oversensing appeared to be due to sensing atrial activity and not due to lead noise.It was suspected that the oversensing was due to the location of the left ventricular lead since the leads were switched in the header.Device was reprogrammed, and the issue was resolved.The patient was stable post programming changes.
 
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Brand Name
UNIFY ASSURA CRT-D RF HV
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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8580729
MDR Text Key144093376
Report Number2938836-2019-03392
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508186
UDI-Public05414734508186
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
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 05/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Model NumberCD3357-40C
Device Catalogue NumberCD3357-40C
Device Lot NumberA000060040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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