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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT ACCEL DR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT ACCEL DR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2215-36
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Upon receipt, the device was found to be in backup vvi (bvvi) mode.Review of the device image showed the cause of the bvvi operation was due to two parity errors that occurred within 32 seconds of each other.Iram testing was performed and the cause of the error was determined to be due to a u2 anomaly.
 
Event or Problem Description
This report is to advise of an event observed during analysis.
 
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Brand Name
CURRENT ACCEL DR, 36J
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8379569
Report Number2938836-2019-01470
Device Sequence Number2978350
Product Code NVZ
UDI-Device Identifier05414734502641
UDI-Public05414734502641
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/28/2019
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 Date01/31/2011
Device Model NumberCD2215-36
Device Lot Number2924001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/13/2019
Initial Report FDA Received Date02/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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