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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; Pulse generator, permanent, implantable
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; Pulse generator, permanent, implantable Back to Search Results
Model Number PM2240
Device Problem No Pacing (3268)
Patient Problems Dyspnea (1816); Dizziness (2194)
Event Type  malfunction  
Event Description
It was reported that the patient presented in clinic due to dizziness and dyspnea.Device interrogation revealed loss of low voltage output on the implantable cardioverter defibrillator (icd).Programming changes were performed to resolve the issue.The patient was in stable condition.
 
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Brand Name
ASSURITY RF DR
Type of Device
Pulse generator, permanent, implantable
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 Key19218274
MDR Text Key341465442
Report Number2017865-2024-40142
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier05414734507073
UDI-Public(01)05414734507073(10)P000064640(17)200131
Combination Product (y/n)N
Reporter Country CodeCA
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 Nurse
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Model NumberPM2240
Device Lot NumberP000064640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/10/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/13/2018
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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