5356 VERITY DR, AB 20 55 184

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-30 for 5356 VERITY DR, AB 20 55 184 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

Event Text Entries

[185715365] 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


[185715366] It was reported that on (b)(6) 2019, during the implant procedure, the lead could not be placed into the device. Several unsuccessful attempts were made to insert the lead into the device. The device was replaced by another device and the procedure was completed. No adverse consequences reported on the patient. The physician mentioned whether there is something wrong with the device. The patient is stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2938836-2020-02323
MDR Report Key9901635
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-12-30
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-11-09
Date Added to Maude2020-03-30
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 Name5356 VERITY DR, AB 20 55 184
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeDXY
Date Received2020-03-30
Model Number5356
Catalog Number5356
Lot NumberP000071084
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
10 2020-03-30

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