ZEPHYR XL DR 5826

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 ZEPHYR XL DR 5826 manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185942469] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185942470] Patient female, (b)(6) old, (b)(6) kg. Abbott dual-chamber pacemaker was implanted more than 10 years ago due to third-degree atrioventricular block. Recently coming to the hospital for testing, (b)(6) found that the pacemaker battery was about to run out, so he decided to replace the pacemaker. It was replaced on (b)(6), 2020. The pacemaker model was 5826 and the serial number was (b)(4). The patient found that the pacemaker's current consumption was 41 microamperes when the pacemaker programed the patient before discharge from the hospital today. The remaining life of the device is shown as 1. 75-2. 75 years. In the afternoon, i personally tried to adjust the parameters, but the current consumption of the pacemaker was still about 40 microamperes. (b)(6) will perform 5826 replacement surgery on the patient later. The product will be sent to the company for further inspection after it is taken out in the future.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04500
MDR Report Key9908492
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-08-09
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 DR
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeNVZ
Date Received2020-03-31
Model Number5826
Catalog Number5826
Lot NumberP000086315
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-31

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