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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 Capture (1081); High impedance (1291); Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2022-01705. It was reported that the patient presented to the clinic for a lead revision procedure. Upon interrogation pre-procedure, high pacing impedance and loss of capture were detected on the right ventricular (rv) lead and the pacemaker. The pacemaker was explanted and replaced. The rv lead was disconnected and reconnected to the newly implanted pacemaker on (b)(6) 2022. The patient was discharged without any complications.
 
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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 Key14139749
MDR Text Key289489655
Report Number2017865-2022-08274
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000135664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2021
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: 04/19/2022 Patient Sequence Number: 1
Treatment
QUARTET LEFT VENTRICULAR LEAD; TENDRIL STS RIGHT ATRIAL LEAD
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