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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD1215-36
Medical Device Problem Code Data Problem (3196)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/20/2018
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 the implantable cardioverter defibrillator exhibited a longevity estimate of 3 years during device check in (b)(6) 2018.During a device interrogation on 11/20/18, the device exhibited a longevity estimate of less than 3 months.The physician was not concerned with the diagnostics anomaly as the battery depletion trend looked normal.There were no adverse consequences to the patient.No further information was available.
 
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Brand Name
CURRENT ACCEL VR, 36J
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key8129858
Report Number2017865-2018-18275
Device Sequence Number252655
Product Code NVZ
UDI-Device Identifier05414734502634
UDI-Public05414734502634
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/04/2018
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 Health Professional
Device Expiration Date03/31/2011
Device Model NumberCD1215-36
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 11/20/2018
Initial Report FDA Received Date12/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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