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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE IDENTITY ADXDR DUAL-CHAMBER PACEMAKER; DUAL CHAMBER PACEMAKER
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ST. JUDE MEDICAL ST. JUDE IDENTITY ADXDR DUAL-CHAMBER PACEMAKER; DUAL CHAMBER PACEMAKER Back to Search Results
Model Number 5380 DDDR
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 04/07/2014
Event Type  Injury  
Event Description
The pt presented to the hospital's same-day surgery on (b)(6) 2014 for replacement of a dual chamber permanent pacemaker.The original pacemaker was implanted at the hospital on (b)(6) 2007.The pt was described as having preoperative diagnosis of sick sinus syndrome with end-of-life pulse generator.The pt was described as having loc, mac anesthesia for the procedure.Documentation of the procedure by the surgeon and cardiologist revealed that care was taken to avoid injury to the existing leads.The pacemaker was mobilized to the pocket.The two leads were disconnected from the previous pacemaker and connected to a new st jude dual-chamber permanent pacemaker.The surgeon documented no complications as well as the pt tolerated the procedure well and left the operating room in satisfactory condition.No further information was found related to the initial placement on (b)(6) 2007.
 
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Brand Name
ST. JUDE IDENTITY ADXDR DUAL-CHAMBER PACEMAKER
Type of Device
DUAL CHAMBER PACEMAKER
Manufacturer (Section D)
ST. JUDE MEDICAL
sylmar CA
MDR Report Key3931232
MDR Text Key4536022
Report Number3931232
Device Sequence Number1
Product Code DXY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5380 DDDR
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/14/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/07/2014
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer04/14/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
Patient Weight64
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