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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
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MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number 6947M72
Medical Device Problem Codes Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/26/2020
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 the right ventricular (rv) lead had a lead integrity alert (lia) triggered by high rate non-sustained episodes and sensing integrity counter (sic).In addition, the lead had high thresholds and t-wave oversensing (twos) and oversensing was noted on stored electrograms (egm).The lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
SPRINT QUATTRO SECURE MRI SURESCAN
Common Device Name
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10987834
Report Number2649622-2020-24205
Device Sequence Number779491
Product Code NVY
UDI-Device Identifier00643169550964
UDI-Public00643169550964
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/10/2020
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 Date07/22/2022
Device Model Number6947M72
Device Catalogue Number6947M72
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2020
Initial Report FDA Received Date12/10/2020
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
DVFB1D4 ICD
Patient Age14 YR
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