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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 1207-36
Medical Device Problem Code Data Problem (3196)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/04/2019
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 patient presented in clinic for follow-up.Upon interrogation of the implantable cardioverter defibrillator.Six months ago, the battery longevity was 2.4 yrs, during interrogation on (b)(6) 2019, the longevity was less than 3 months.The device was explanted and replaced.The patient was stable.
 
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Brand Name
CURRENT VR RF
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key9497112
Report Number2017865-2019-18221
Device Sequence Number1202901
Product Code LWS
UDI-Device Identifier05414734501941
UDI-Public05414734501941
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/23/2020
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 Model Number1207-36
Device Catalogue Number1207-36
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/04/2019
Supplement Date Received by Manufacturer04/20/2020
Initial Report FDA Received Date12/19/2019
Supplement Report FDA Received Date04/23/2020
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 Age60 YR
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