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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 Failure to Interrogate (1332); Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  Injury  
Event Description
Related manufacturer reference numbers: 2017865-2021-39810. It was reported that the patient presented in clinic for follow-up. Upon interrogation, it was found that the right ventricular (rv) lead had increased capture threshold. Rv lead dislodgement was suspected. It was also noted that the pacemaker (pm) exhibited slow radio frequency (rf) telemetry and it was difficult to program the pm. Patient presented in clinic for rv lead revision. Upon interrogation prior to procedure, it was found that pm had no rf telemetry. The pm and the rv lead were both explanted and replaced. Patient condition was stable.
 
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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 Key13054764
MDR Text Key282584074
Report Number2017865-2021-39809
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000119560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2021
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: 12/21/2021 Patient Sequence Number: 1
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