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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 Codes Defibrillation/Stimulation Problem (1573); Device Sensing Problem (2917)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 1103 hvad pump, implanted on (b)(6) 2019 and 1125 hvad outflow graft, implanted on (b)(6) 2019.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) withheld therapies in a true ventricular tachycardia (vt) episode due to stability and wavelet detection.The icd was reprogrammed and remains in use.No 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 Key9336805
Report Number3004209178-2019-22038
Device Sequence Number2244121
Product Code LWS
UDI-Device Identifier00643169929753
UDI-Public00643169929753
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/18/2019
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 Date05/14/2019
Device Model NumberDVAB1D1
Device Catalogue NumberDVAB1D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2019
Initial Report FDA Received Date11/18/2019
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 Life Threatening; Required Intervention;
Patient Age43 YR
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