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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2211-36
Medical Device Problem Code Reset Problem (3019)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional information was requested but not provided.
 
Event or Problem Description
It was reported that the patient presented after experiencing multiple inappropriate shocks that were linked to lead damage.Upon review, the patient's implantable cardioverter defibrillator was found to be in reset mode.A full system revision was scheduled.The patient was stable.
 
Event or Problem Description
It was reported that the patient's system was explanted on september 30, 2020.The patient was stable throughout.
 
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Brand Name
CURRENT+ DR DUAL-CHAMBER 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 Key10718290
Report Number2017865-2020-15967
Device Sequence Number19618064
Product Code NVZ
UDI-Device Identifier05414734503723
UDI-Public05414734503723
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 12/01/2020
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 Expiration Date01/31/2016
Device Model NumberCD2211-36
Device Catalogue NumberCD2211-36
Device Lot Number4734080
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/29/2020
Supplement Date Received by Manufacturer11/28/2020
Initial Report FDA Received Date10/22/2020
Supplement Report FDA Received Date12/01/2020
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;
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