QUADRA ASSURA MP ICD CD3369-40Q

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-27 for QUADRA ASSURA MP ICD CD3369-40Q manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

Event Text Entries

[168430014] It was reported that due to patient? S weight and tissue loss as compared to implant date, physician requested to re-implant device submuscular. Possible infection resulted in device replacement. The device was explanted and replaced. The patient is recovering.
Patient Sequence No: 1, Text Type: D, B5


[176521757] The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[176521758] New information notes the patient is stable.
Patient Sequence No: 1, Text Type: D, B5


[182478993] Analysis was normal. No anomalies were found.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2938836-2019-16749
MDR Report Key9387802
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-27
Date of Report2019-11-27
Date of Event2019-11-12
Date Mfgr Received2019-11-12
Device Manufacturer Date2016-09-07
Date Added to Maude2019-11-27
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 ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUADRA ASSURA MP ICD
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeNIK
Date Received2019-11-27
Model NumberCD3369-40Q
Catalog NumberCD3369-40Q
Lot NumberA000027992
Device Expiration Date2018-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Address645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-27

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