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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3286
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report.
 
Event or Problem Description
Reference mfr report: 1627487-2019-03341.It was reported that the patient's lead was confirmed via x-ray to have migrated.As a result, surgical intervention was taken on (b)(6) 2019 to have both leads repositioned.Issue was resolved.
 
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Brand Name
LAMITRODE S-8 LEAD KIT, 60CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8413579
Report Number1627487-2019-03323
Device Sequence Number1785421
Product Code LGW
UDI-Device Identifier05415067017833
UDI-Public05415067017833
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/25/2019
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 Date03/31/2017
Device Model Number3286
Device Lot Number5037486
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 02/21/2019
Supplement Date Received by Manufacturer03/15/2019
Initial Report FDA Received Date03/12/2019
Supplement Report FDA Received Date03/25/2019
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: 3186, SCS LEAD
Outcome Attributed to Adverse Event Other;
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