Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/10/2014
Event Type  Injury  
Event Description
It was reported the patient (germany) lost stimulation.Lead diagnostic testing revealed invalid impedance measurements.In turn, the patient will undergo surgical intervention at a later date.
 
Event Description
Follow-up revealed the patient's lead was explanted and replaced which resolved the issue.
 
Event Description
Follow-up revealed the patient was implanted with two leads prior to surgical intervention.The device information for the second lead is unknown at this time.
 
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.
 
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
Results the complaint for ¿invalid impedance¿ was confirmed.As received, microscopic inspection revealed that the lead had a kink 16.5 cm from the stimulation end where all of the internal wires were broken, and a cam impression from the swift-lock anchor.As there was no breach of the outer tubing and invalid impedance was observed prior to the revision, the fracture is consistent with an overstress condition the lead was subjected to distal end of the swift-lock while it was still implanted.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
Additional information received identified the patient's explanted lead was fractured.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4370913
MDR Text Key5117442
Report Number1627487-2014-25717
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup
Report Date 03/12/2015
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2015
Device Model Number3186
Device Lot Number3903721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-