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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 Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/07/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the full lead was returned.Analysis was performed and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
About three weeks post implant, that the right ventricular (rv) lead had pulled back and had no capture at five volts.The lead was explanted 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 Key7254520
Report Number2649622-2018-00695
Device Sequence Number1213773
Product Code LWS
UDI-Device Identifier00643169535909
UDI-Public00643169535909
Combination Product (Y/N)N
Initial Reporter StateTX
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date12/11/2017
Device Model Number693558
Device Catalogue Number693558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2017
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;
Patient Age78 YR
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