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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
Event Date 09/06/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient was experiencing uncomfortable sensation.The patient also reported having developed weakness in both legs and urinary incontinence.In turn, surgical intervention was undertaken wherein the entire system as explanted to address the issue.
 
Event Description
Additional information received indicated the patient suffered temporary paralysis following the event.This has since resolved following physical therapy.The patient still does not have complete feeling in the buttocks.
 
Manufacturer Narrative
As received, the octrode lead passed all electrical testing.No root cause was identified for the reported event.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10610811
MDR Text Key209327535
Report Number1627487-2020-31982
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017246
UDI-Public05415067017246
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/26/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot Number6329658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received09/30/2020
Supplement Dates Manufacturer Received11/11/2020
12/28/2020
Supplement Dates FDA Received12/02/2020
01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
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