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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 of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that the patient¿s lead had migrated which was confirmed via x-ray.As a result, surgical intervention took place on (b)(6)2019 wherein the patient¿s lead was repositioned only.Therapy has been restored post-op.
 
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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 Key8735758
Report Number1627487-2019-07412
Device Sequence Number2573235
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
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/26/2019
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 Date01/31/2018
Device Model Number3286
Device Lot Number5376978
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 06/13/2019
Initial Report FDA Received Date06/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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