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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR; Implantable pulse generator, pacemaker (non-CRT)
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR; Implantable pulse generator, pacemaker (non-CRT) Back to Search Results
Model Number PM2112
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem Discomfort (2330)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
It was reported the patient presented in clinic for follow up.Upon interrogation, it was discovered the pacemaker was in backup mode due to electromagnetic interference.The pacemaker was successfully restored.There were no patient consequences.
 
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Brand Name
ACCENT DR
Type of Device
Implantable pulse generator, pacemaker (non-CRT)
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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18951629
MDR Text Key338479518
Report Number2017865-2024-35565
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P880086
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 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Model NumberPM2112
Device Lot NumberS000072498
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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