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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OCTRODE; SCS LEAD
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OCTRODE; SCS LEAD Back to Search Results
Model Number 3186
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/04/2014
Event Type  Injury  
Event Description
Follow-up information revealed the patient regained stimulation therapy postoperative.
 
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
It was reported the patient (b)(6) lost stimulation abruptly.Diagnostic testing revealed high impedance readings on multiple lead contacts.It was also reported the patient's lead was fractured.Subsequently, the patient underwent surgical intervention on (b)(6) 2014, where the lead was explanted and replaced.Concomitant medical products: model 1192, scs anchor, implant date: unknown.
 
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 ¿no stimulation¿ was confirmed.Microscopic inspection of lead revealed a kink with all broken wires 33cm from the stimulation end.As there was no breach of the outer tubing and no stimulation was observed prior to the revision, the fracture was consistent with an overstress condition the lead was subjected to while inside the patient.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
Type of Device
SCS LEAD
Manufacturer Contact
jennifer shepard
jennifer shepard
6901 preston road
plano 75024
9725264657
MDR Report Key4369468
MDR Text Key5493865
Report Number1627487-2014-23841
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUK
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 03/11/2015
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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