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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2215-36Q
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
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 the implantable cardioverter defibrillator exhibited an unknown malfunction.The device was explanted and replaced.The patient condition was unknown.
 
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Brand Name
CD2215-36Q CURRENT ACCEL DR ICD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11108505
Report Number2017865-2021-00051
Device Sequence Number3608980
Product Code NVZ
UDI-Device Identifier05414734503075
UDI-Public05414734503075
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2014
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2011
Device Model NumberCD2215-36Q
Device Catalogue NumberCD2215-36Q
Device Lot Number3115929
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 12/14/2020
Initial Report FDA Received Date01/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
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