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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT VR RF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 1207-36
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/18/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The initial medical device report was submitted via an alternative summary report on 01/31/2018 under authorization number e19974033 for manufacturer abbott under registration number (b)(4).Analysis was normal.No anomalies were found.
 
Event or Problem Description
It was reported that the patient presented in the operation room.The pulse generator and right ventricular lead were explanted due to infection.No further information was available.The initial medical device report was submitted via an alternative summary report on 01/31/2018 under authorization number e19974033 for manufacturer abbott under registration number (b)(4).
 
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Brand Name
CURRENT VR RF
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8461240
Report Number2938836-2019-02234
Device Sequence Number11494522
Product Code LWS
UDI-Device Identifier05414734501941
UDI-Public05414734501941
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2010
Device Model Number1207-36
Device Lot Number0002686960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/27/2019
Initial Report FDA Received Date03/28/2019
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 Age53 YR
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