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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2021
Event Type  malfunction  
Manufacturer Narrative
Further information was requested but was not yet received.
 
Event Description
It was reported that patient's pacemaker exhibited far r wave oversensing. No intervention was performed. The patient's status was unknown.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12770895
MDR Text Key280462991
Report Number2017865-2021-35986
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000097861
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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