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 Medtronic Singapore Operations.

Event Text Entries

[186356193] Concomitant medical products: tyrx-aae absorbable antibiotic envelope implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186356234] It was reported that a pocket infection occurred with discharge at the incision site less than a month after the implant of a cardiac resynchronization therapy defibrillator (crt-d) system with an absorbable antibacterial envelope. The wound was opened, swabbed, and debrided. The pocket was irrigated and closed. The crt-d system remains in use and antibiotic treatment was provided. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008973940-2020-00767
MDR Report Key9903546
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-05-14
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 G1MEDTRONIC SINGAPORE OPERATIONS
Manufacturer Street49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE
Manufacturer CitySINGAPORE 486056
Manufacturer CountrySG
Manufacturer Postal Code486056
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
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SINGAPORE OPERATIONS
Manufacturer Address49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE SINGAPORE 486056 SG 486056


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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