SPRINT QUATTRO SECURE S MRI SURESCAN 6935M62

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for SPRINT QUATTRO SECURE S MRI SURESCAN 6935M62 manufactured by Mpri.

Event Text Entries

[185921827] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185921828] It was reported that there was high coil impedance on the right ventricular (rv) lead. The rv lead currently remains in use and a re vision may be completed at a future date. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[186016952] Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2649622-2020-06712
MDR Report Key9905845
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-28
Date Mfgr Received2020-03-31
Device Manufacturer Date2018-02-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MPRI
Manufacturer StreetROAD 149 KM 56.3
Manufacturer CityVILLALBA PR 00766
Manufacturer CountryUS
Manufacturer Postal Code00766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPRINT QUATTRO SECURE S MRI SURESCAN
Generic NameDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Product CodeLWS
Date Received2020-03-31
Model Number6935M62
Catalog Number6935M62
Device Expiration Date2020-02-15
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMPRI
Manufacturer AddressROAD 149 KM 56.3 VILLALBA PR 00766 US 00766


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.