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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA MRI AF S VR ICD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA MRI AF S VR ICD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVFC3D4
Medical Device Problem Code Pacing Problem (1439)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/15/2018
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 an interrogation report from the implantable cardioverter defibrillator (icd) indicated that there were possible inappropriate pacing spikes.The icd was remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
VISIA MRI AF S VR ICD
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 Key7957314
Report Number3004209178-2018-22835
Device Sequence Number13667202
Product Code LWS
UDI-Device Identifier00643169566446
UDI-Public00643169566446
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/11/2018
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 Date05/14/2018
Device Model NumberDVFC3D4
Device Catalogue NumberDVFC3D4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/15/2018
Initial Report FDA Received Date10/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age58 YR
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