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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 High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2014
Event Type  Injury  
Event Description
It was reported lead diagnostic testing identified high impedance measurements on the patient's (b)(6) lead.In turn, the patient's lead was removed and replaced which resolved the issue.There were no known patient complications reported.Additionally, it is unknown if the event occured during the patient's permanent or revision procedure.
 
Event Description
Follow-up revealed the patient experienced high impedance measurements during his trial procedure.
 
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.
 
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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
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4370910
MDR Text Key5237323
Report Number1627487-2014-25716
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
Report Date 03/06/2015
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 Date03/28/2016
Device Model Number3186
Device Lot Number4848378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age44 YR
Patient Weight70
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