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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problem Cut In Material (2454)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/08/2015
Event Type  Injury  
Event Description
Follow-up identified the reported lead was explanted and replaced.Effective stimulation has been restored.
 
Event Description
Follow-up identified the reason for the initial surgical procedure was to explant a competitor's therapy system.
 
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.
 
Event Description
The patient ((b)(6)) is implanted with one scs and two pns systems.It was reported during the patient's lead revision procedure, the physician inadvertently cut the patient's right lead resulting in loss of stimulation.The patient is receiving stimulation from the left lead.Surgical intervention will take place at a later date to address the affected lead.The device information on the other implantable leads and the event date is unknown at this time.
 
Manufacturer Narrative
(b)(4).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
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano, tx 7502 4
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4509661
MDR Text Key5478569
Report Number1627487-2015-21035
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/02/2015
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? Yes
Device Operator Health Professional
Device Expiration Date03/28/2013
Device Model Number3186
Device Lot Number3350655
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/02/2015
Initial Date FDA Received02/11/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received03/05/2015
03/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2011
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 3716, SCS IPG
Patient Outcome(s) Other;
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