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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH SCS LEADS

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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH SCS LEADS Back to Search Results
Model Number 3189
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Erosion (1750)
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Device 1 of 2: reference mfr report #1627487-2019-02602. It was reported the patient experienced erosion and both leads appeared to be protruding out of the skin. In turn, the patient underwent surgical intervention wherein both leads were explanted and replaced.
 
Manufacturer Narrative
It was inadvertently reported in the initial report that the leads were replaced, rather the leads were explanted but not replaced.
 
Event Description
Device 1 of 2. Reference mfr report #1627487-2019-02602.
 
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Brand NameOCTRODE LEAD KIT, 90CM LENGTH
Type of DeviceSCS LEADS
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8384795
MDR Text Key137659711
Report Number1627487-2019-02601
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/13/2020
Device Model Number3189
Device Lot Number6351243
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2019 Patient Sequence Number: 1
Treatment
MODEL 3189, SCS LEADS
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