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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40Q
Medical Device Problem Code Telemetry Discrepancy (1629)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/11/2019
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that during a mod transmission, large spikes were noted that were not sensed.It was suspected that it was either external or a problem with telemetry while sending the report.The device function was not affected.No intervention was performed.The patient was stable.
 
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Brand Name
UNIFY CRT-D
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8643102
Report Number2938836-2019-04127
Device Sequence Number13985694
Product Code NIK
UDI-Device Identifier05414734504393
UDI-Public05414734504393
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/28/2013
Device Model NumberCD3231-40Q
Device Catalogue NumberCD3231-40Q
Device Lot Number3481130
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2019
Initial Report FDA Received Date05/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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