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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ S VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ S VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVBC3D1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) system was removed due to systemic infection.No further patient complications have been reported as a result of this event.
 
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Brand Name
EVERA¿ S VR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key9377460
Report Number3004209178-2019-22658
Device Sequence Number19348042
Product Code LWS
UDI-Device Identifier00643169929852
UDI-Public00643169929852
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/26/2019
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 Lay User/Patient
Device Expiration Date12/28/2018
Device Model NumberDVBC3D1
Device Catalogue NumberDVBC3D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/04/2019
Initial Report FDA Received Date11/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
693565 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age76 YR
Patient Weight91
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