Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MPRI SPRINT QUATTRO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6946M55
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the proximal segment of the lead was returned, analyzed, and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient had developed an infection "not at the device site" and vegetation was noticed on the right ventricular (rv) lead.The implantable cardioverter defibrillator (icd) and rv lead were extracted.No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPRINT QUATTRO
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7254863
Report Number2649622-2018-00864
Device Sequence Number140292
Product Code LWS
UDI-Device Identifier00643169335561
UDI-Public00643169335561
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2018
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 Date08/16/2018
Device Model Number6946M55
Device Catalogue Number6946M55
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2017
Initial Report FDA Received Date02/08/2018
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 Hospitalization; Required Intervention;
Patient Age76 YR
-
-