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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CURRENT DR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC. CURRENT DR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 2207-36
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Failure event observed during analysis.Final analysis found low pacing lead impedance (pli) measurements.Ate was performed to further investigate and plitrim1 test failed.This failure is consistent with the impedance anomaly found in the lab and is consistent with a device circuit anomaly.
 
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.
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8187098
Report Number2938836-2018-13188
Device Sequence Number2016062
Product Code LWS
UDI-Device Identifier05414734501927
UDI-Public05414734501927
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/20/2018
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 Date10/31/2011
Device Model Number2207-36
Device Lot Number3122709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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