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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH Back to Search Results
Model Number 1458Q
Device Problem Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Voluntary event report was received.Medwatch: mw5147149.
 
Event Description
It was reported that the patient presented in clinic for a follow up.Device interrogation revealed low pacing impedance on the right ventricular (rv) lead.No changes or intervention were reported.The patient condition was unknown.
 
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Brand Name
QUARTET
Type of Device
NO MATCH
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 Key18253826
MDR Text Key329560291
Report Number2017865-2023-93729
Device Sequence Number1
Product Code NIK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1458Q
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/13/2023
Initial Date FDA Received12/04/2023
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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