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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 694775
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 06/26/2019
Type of Reportable Event Death
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 was having their right ventricular (rv) lead electively replaced, but during the procedure, the extraction laser perforated the superior vena cava and the patient had an enormous loss of blood and the patient died.
 
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Brand Name
SPRINT QUATTRO SECURE MRI SURESCAN
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8758781
Report Number2649622-2019-11506
Device Sequence Number1489559
Product Code LWS
UDI-Device Identifier00613994740939
UDI-Public00613994740939
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/03/2019
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? No
Operator of Device Lay User/Patient
Device Expiration Date10/14/2013
Device Model Number694775
Device Catalogue Number694775
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2019
Initial Report FDA Received Date07/03/2019
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
D314VRG ICD
Outcome Attributed to Adverse Event Death;
Patient Age55 YR
Patient Weight150
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