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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI SPRINT QUATTRO SECURE S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 693558
Medical Device Problem Codes Capturing Problem (2891); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/02/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.
 
Event or Problem Description
It was reported that the patients right ventricular (rv) lead exhibited rising and high thresholds.The right atrial (ra) lead also displayed high thresholds along with intermittent capture.Both rv and ra lead have been extracted and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
SPRINT QUATTRO SECURE S
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key6782419
Report Number2649622-2017-09288
Device Sequence Number999007
Product Code LWS
UDI-Device Identifier00643169535909
UDI-Public00643169535909
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/02/2017
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 Date11/30/2017
Device Model Number693558
Device Catalogue Number693558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2017
Initial Report FDA Received Date08/09/2017
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 Age82 YR
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