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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT DR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT DR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 2207-36
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Failure event observed during analysis.Final analysis found loss of hv output due to transistor damage.The cause of transistor damage is unknown.
 
Event or Problem Description
This report is to advise of an event observed during analysis.
 
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Brand Name
CURRENT DR RF
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8547539
Report Number2938836-2019-03091
Device Sequence Number13885759
Product Code LWS
UDI-Device Identifier05414734501927
UDI-Public05414734501927
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/24/2019
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 Other
Device Expiration Date09/30/2009
Device Model Number2207-36
Device Lot Number2708708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2019
Initial Report FDA Received Date04/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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