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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI SPRINT QUATTRO SECURE; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 694758
Medical Device Problem Codes Over-Sensing (1438); Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/28/2017
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 patients right ventricular (rv) lead had triggered a lead integrity alert (lia) with a one time impedance spike, high rate non-sustained episodes, and t-wave oversensing (twos).Follow-up with an allied health professional (ahp) at the patient's clinic revealed reprogramming had been completed.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
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7092878
Report Number2649622-2017-14205
Device Sequence Number1574561
Product Code LWS
UDI-Device Identifier00643169535961
UDI-Public00643169535961
Combination Product (Y/N)N
Initial Reporter StateTN
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 company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/06/2017
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 Date03/15/2018
Device Model Number694758
Device Catalogue Number694758
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/02/2017
Initial Report FDA Received Date12/07/2017
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
(B)(4), ICD
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
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