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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR SR; Pulse generator, permanent, implantable
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR SR; Pulse generator, permanent, implantable Back to Search Results
Model Number 5620
Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2023
Event Type  malfunction  
Event Description
It was reported, that the patient presented in the clinic.Upon interrogation, it was observed, that the electrocardiogram was missing.Furthermore, the device exhibited noise.No intervention was made.The patient was stable throughout.
 
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Brand Name
ZEPHYR SR
Type of Device
Pulse generator, permanent, implantable
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17376835
MDR Text Key319844380
Report Number2017865-2023-36510
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier05414734501606
UDI-Public05414734501606
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2018
Device Model Number5620
Device Lot NumberS000034889
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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