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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

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ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 1488TC
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/25/2013
Event Type  malfunction  
Event Description
This lead was implanted on (b)(6) 2003 and was capped on (b)(6) 2013 due to an unknown product performance issue.The physician was dr.(b)(6).No other information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17535492
MDR Text Key321348730
Report NumberMW5142389
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2013
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? No
Device Model Number1488TC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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