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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 Code High impedance (1291)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 407645 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the high voltage portions of the right ventricular (rv) lead had high impedance.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 MRI SURESCAN
Common Device Name
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10547633
Report Number2649622-2020-17874
Device Sequence Number1217750
Product Code NVY
UDI-Device Identifier00643169309739
UDI-Public00643169309739
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/17/2020
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 Date07/10/2016
Device Model Number6947M72
Device Catalogue Number6947M72
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/05/2020
Initial Report FDA Received Date09/17/2020
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
DTBA1QQ CRT-D, 429888 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age68 YR
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