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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problem High impedance (1291)
Patient Problems Failure of Implant (1924); Scar Tissue (2060); Inadequate Pain Relief (2388)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
Related manufacturer reference number: 3006705815-2021-05368.It was reported that patient was experiencing high impedances on one lead and the other lead was fractured.Patient had scar tissues as well as such surgical intervention took place where in both the leads were explanted and replaced.Reportedly effective therapy was restored.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
SCS LEAD
MDR Report Key12716093
MDR Text Key279006183
Report Number3006705815-2021-05369
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,health
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/23/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000068567
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2018
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 3186, SCS LEAD
Patient Outcome(s) Other;
Patient Weight113
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