ZEPHYR XL SR 5626

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for ZEPHYR XL SR 5626 manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185710554] Further information was requested but not received.
Patient Sequence No: 1, Text Type: N, H10


[185710555] Related manufacturer reference number:2017865-2020-04379. It was reported that the patient presented with an infection. The device was explanted, and the lead was capped. Further information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04377
MDR Report Key9898036
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-19
Date Mfgr Received2020-03-09
Device Manufacturer Date2008-08-19
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-SYLMAR)
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZEPHYR XL SR
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeNVZ
Date Received2020-03-30
Returned To Mfg2020-03-09
Model Number5626
Catalog Number5626
Lot Number2700052
Device Expiration Date2010-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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