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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH SCS TRIAL LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH SCS TRIAL LEAD Back to Search Results
Model Number 3086
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Date 04/04/2019
Event Type  Injury  
Event Description
Reference mfr. Report number: 3006705815-2019-01526. It was reported that patient developed epidural abscess post scs trial. As a result, patient underwent surgical intervention to resolve the issue. Patient is also treated with antibiotics. Post procedure patient is doing better.
 
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Brand NameOCTRODE TRIAL LEAD KIT, 60CM LENGTH
Type of DeviceSCS TRIAL LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8565681
MDR Text Key143578639
Report Number3006705815-2019-01528
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,health
Reporter Occupation
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Model Number3086
Device Lot NumberA000073455
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 Received04/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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: 04/30/2019 Patient Sequence Number: 1
Treatment
MODEL 3086, TRIAL SCS LEAD
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