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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD Back to Search Results
Model Number 3183
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
Event or Problem Description
Device 5 of 6.Reference mfr report # 1627487-2019-02487, reference mfr report # 1627487-2019-02488, reference mfr report # 1627487-2019-02489, reference mfr report # 1627487-2019-02490, reference mfr report # 1627487-2019-02492.It was reported that patient had both of their pns systems explanted.Per patient, the systems were no longer working and wanted to have them explanted.
 
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Brand Name
OCTRODE LEAD KIT, 30CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8358359
Report Number1627487-2019-02491
Device Sequence Number2229195
Product Code LGW
UDI-Device Identifier05414734406123
UDI-Public05414734406123
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/21/2019
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 Date01/31/2017
Device Model Number3183
Device Lot Number4995206
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 02/06/2019
Initial Report FDA Received Date02/21/2019
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
3183, SCS LEAD; 3186, SCS LEAD (2); 3662, SCS IPG (2)
Outcome Attributed to Adverse Event Other;
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