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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Date 06/27/2022
Event Type  Injury  
Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements. The device met specifications prior to leaving abbott manufacturing facilities. Review of the sterilization records confirmed normal sterilization cycles for the products. The cause of infection could not be determined. The reported event will continue to be monitored and trended. Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 2017865-2022-15408; related manufacturer reference number: 2017865-2022-15409. It was reported that the patient presented with skin erosion and infection at implanted device pocket site. The pacemaker, right ventricular lead and left ventricular lead were explanted due to infection. The patient was in stable condition.
 
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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 Key15047972
MDR Text Key296126076
Report Number2017865-2022-15407
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)Y
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
Report Date 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2022
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000106441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
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: 07/18/2022 Patient Sequence Number: 1
Treatment
TENDRIL MRI
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