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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
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/05/2014
Event Type  malfunction  
Event Description
It was reported the patient has been experiencing ineffective stimulation and his system is autoreducing.Diagnostic testing indicated high impedance readings on several contacts.X-rays revealed lead fracture.
 
Event Description
Follow-up revealed the patient underwent surgical intervention on (b)(6) 2015 to implant a new lead to address the new pain pattern.However, the procedure was abandoned after a csf leak.The patient's csf leak is reported under mfr.Report #: 1627487-2015-01123.The patient will undergo surgical intervention at a later date to explant the lead.
 
Manufacturer Narrative
Sjm 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.Sjm defers to the patient's physician regarding medical history.
 
Manufacturer Narrative
Sjm 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.Sjm defers to the patient's physician regarding medical history.
 
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Brand Name
LAMITRODE TRIPOLE 16C LEAD, 60 CM
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
st. jude medical - neuromodulation
6901 preston rd
plano TX 75024
MDR Report Key4370825
MDR Text Key5115264
Report Number1627487-2014-24434
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2016
Device Model Number3214
Device Lot Number4511476
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL:3789, SCS IPG
Patient Age37 YR
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