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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)
Date of Event 03/02/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
 
Event or Problem Description
Device 1 of 2: reference mfr.Report#1627487-2018-08220.It was reported that the patient never experienced effective stimulation from the scs system.Multiple reprogramming's were attempted to no avail.As such, the scs system was 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 Key7867267
Report Number1627487-2018-08218
Device Sequence Number13944681
Product Code GZB
UDI-Device Identifier05414734406123
UDI-Public05414734406123
Combination Product (Y/N)N
Initial Reporter StateWV
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) 09/11/2018
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 Date07/28/2016
Device Model Number3183
Device Lot Number4702514
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 08/21/2018
Initial Report FDA Received Date09/11/2018
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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