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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 DVAB1D4
Medical Device Problem Codes Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that a lead integrity alert (lia) triggered on the right ventricular (rv) lead due to noise oversensing with high rate non-sustained (hr-ns) and sensing integrity counter (sic) episodes by the implantable cardioverter defibrillator (icd).The physician indicated that the patient had a medical procedure causing the noise oversensing.The device 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 Key10313118
Report Number3004209178-2020-12668
Device Sequence Number16946183
Product Code LWS
UDI-Device Identifier00643169720626
UDI-Public00643169720626
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/28/2020
Device Model NumberDVAB1D4
Device Catalogue NumberDVAB1D4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2020
Initial Report FDA Received Date07/23/2020
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
6935M55 LEAD
Patient Age72 YR
Patient Weight110
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