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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY¿ CORE DR, MRI (US); IMPLANTABLE PACEMAKER PULSE-GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY¿ CORE DR, MRI (US); IMPLANTABLE PACEMAKER PULSE-GENERATOR Back to Search Results
Model Number PM2140
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2023
Event Type  malfunction  
Event Description
It was reported that the patient presented for an implant procedure.During the procedure, the leads were unable to be screwed into the pacemaker header.The pacemaker was not used and replaced.The patient was in stable condition.
 
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Brand Name
ENDURITY¿ CORE DR, MRI (US)
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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18122100
MDR Text Key328503278
Report Number2017865-2023-52275
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup,Followup
Report Date 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPM2140
Device Lot NumberP000176306
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2023
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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