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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2272
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 04/20/2022
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2022-11656, 2017865-2022-11657.It was reported that the patient presented to the clinic with fever and abnormal blood test results.The pacemaker, right atrial (ra) lead, and right ventricular (rv) lead were explanted due to infection.On (b)(6) 2022, the pacemaker, ra lead and rv lead were replaced.The patient was in stable condition throughout the procedure.
 
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.
 
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Brand Name
ASSURITY MRI
Type of Device
IMPLANTABLE 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 Key14598382
MDR Text Key293334049
Report Number2017865-2022-11655
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509589
UDI-Public05414734509589
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P140033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberP000139662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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