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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 Codes Over-Sensing (1438); Decreased Sensitivity (2534); Impedance Problem (2950); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/22/2019
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 right ventricular (rv) defibrillation lead exhibited sudden high pacing thresholds, slowly decreasing r-waves, slowly increasing pacing impedance and short episodes of occasional oversensing.The pace/sense portion of the lead was capped and replaced while the defibrillation portion remains in use.No patient complications have been reported as a result of this event.
 
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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 Key8347617
Report Number2649622-2019-02568
Device Sequence Number1832758
Product Code LWS
UDI-Device Identifier00643169451469
UDI-Public00643169451469
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/18/2019
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date06/02/2018
Device Model Number6944-65
Device Catalogue Number6944-65
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2019
Initial Report FDA Received Date02/18/2019
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 Age61 YR
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