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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI SPRINT QUATTRO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6944-65
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code Ventricular Tachycardia (2132)
Date of Event 08/25/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had therapies withheld due to t-wave oversensing by the right ventricular (rv) lead.The lead was r programmed with no further t-wave oversensing observed in the clinic.The lead remains in use.No further patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key6163380
Report Number2649622-2016-15632
Device Sequence Number1418805
Product Code LWS
UDI-Device Identifier00643169451469
UDI-Public00643169451469
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 09/09/2016
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 Date03/09/2018
Device Model Number6944-65
Device Catalogue Number6944-65
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/09/2016
Supplement Date Received by Manufacturer09/09/2016
Initial Report FDA Received Date12/09/2016
Supplement Report FDA Received Date09/26/2017
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
DDBB1D1 ICD, 4574-53 LEAD
Outcome Attributed to Adverse Event Life Threatening; Required Intervention;
Patient Age73 YR
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