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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF MRI S VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF MRI S VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DVFC3D1
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/27/2020
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 patient's implantable cardioverter defibrillator (icd) was explanted and replaced due to infection at the bottom of their left breast.It was noted that the device had migrated from the sub-pectoral to the bottom of left breast.No further patient complications have been reported as a result of this event.
 
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Brand Name
VISIA AF MRI S VR SURESCAN
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 Key10408433
Report Number3004209178-2020-14113
Device Sequence Number3119979
Product Code LWS
UDI-Device Identifier00643169837829
UDI-Public00643169837829
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/14/2020
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date04/14/2020
Device Model NumberDVFC3D1
Device Catalogue NumberDVFC3D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/27/2020
Initial Report FDA Received Date08/14/2020
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
0154 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age32 YR
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