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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD Back to Search Results
Model Number 3219
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Therapeutic Effects, Unexpected (2099)
Date of Event 03/08/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Device 1 of 2: reference mfr.Report# 3006705815-2018-03418.It was reported that the patient was experiencing stimulation in the wrong location.In turn, the patients system was explanted and replaced.Effective stimulation was confirmed post-op.
 
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Brand Name
LAMITRODE TRIPOLE 16 LEAD, 60 CM
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8185731
Report Number1627487-2018-13284
Device Sequence Number1850415
Product Code LGW
UDI-Device Identifier05415067017628
UDI-Public05415067017628
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/30/2017
Device Model Number3219
Device Lot Number5149289
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2018
Initial Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MODEL 3771, SCS IPG
Outcome Attributed to Adverse Event Other;
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