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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PACING SYSTEM ANALYZER; ACCESSORY
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PACING SYSTEM ANALYZER; ACCESSORY Back to Search Results
Model Number EX3100
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2022
Event Type  malfunction  
Event Description
It was reported that during the procedure, the pacing system analyzer (psa) that was connected to the patient exhibited no low voltage output and failed to do the measurement.The test continued with other method with a good measurement result.The patient was stable throughout the procedure.
 
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Brand Name
MERLIN PACING SYSTEM ANALYZER
Type of Device
ACCESSORY
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 Key15859521
MDR Text Key305628548
Report Number2017865-2022-46600
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503105
UDI-Public05414734503105
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2023
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 NumberEX3100
Device Catalogue NumberEX3100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/04/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received02/02/2023
Supplement Dates FDA Received02/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
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