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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVBB1D1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/26/2021
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 explanted due to an infection.A new system will not be implanted.No further patient complications have been reported as a result of this event.
 
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Brand Name
EVERA XT 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 Key11293344
Report Number3004209178-2021-02130
Device Sequence Number4997863
Product Code LWS
UDI-Device Identifier00643169530300
UDI-Public00643169530300
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 Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date12/14/2017
Device Model NumberDVBB1D1
Device Catalogue NumberDVBB1D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2021
Initial Report FDA Received Date02/08/2021
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 Age70 YR
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