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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS LEAD Back to Search Results
Model Number 3214
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 07/13/2018
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
It was reported the patient received undesired rib stimulation from the scs system.As such, the patient underwent surgical intervention on (b)(6)2018, wherein the lead was repositioned.Reportedly, effective stimulation was restored following the procedure.
 
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Brand Name
LAMITRODE TRIPOLE 16C LEAD, 60 CM
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key7765509
Report Number1627487-2018-07381
Device Sequence Number1705654
Product Code GZB
UDI-Device Identifier05414734406154
UDI-Public05414734406154
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 Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/08/2018
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 Date01/05/2020
Device Model Number3214
Device Lot Number6251135
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 07/13/2018
Initial Report FDA Received Date08/08/2018
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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