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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVAB1D1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hematoma (1884); Unspecified Infection (1930)
Date of Event 12/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5092-52 lead, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that an infection occurred approximately two months post implantable cardioverter defibrillator (icd) changeout procedure after hematoma.The icd system was explanted and antibiotic treatment was necessary.No further patient complications have been reported as a result of this event.
 
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Brand Name
VISIA AF 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 Key9545126
Report Number3004209178-2020-00110
Device Sequence Number2341886
Product Code LWS
UDI-Device Identifier00643169720619
UDI-Public00643169720619
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/03/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date10/28/2019
Device Model NumberDVAB1D1
Device Catalogue NumberDVAB1D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2019
Initial Report FDA Received Date01/03/2020
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 Hospitalization; Required Intervention;
Patient Age64 YR
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