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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 Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Event Description
It was reported that the patient presented remotely via merlin. Net. A review of the transmission revealed that the pacemaker exhibited far r oversensing on the atrial channel which result in an inappropriate mode switch. It was also noted that a decrease in p wave amplitude occurred. Programming changes were discussed but no intervention was performed. No patient symptoms were reported.
 
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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 Key14365955
MDR Text Key291464796
Report Number2017865-2022-09642
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
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 Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000110205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2022 Patient Sequence Number: 1
Treatment
1458Q/86 QUARTETLEADS; BI,TINED,IS-1; BI,TINED,VS-1
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