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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3186
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.

 
Event Description

Related manufacturer report number 3006705815-2019-03109. Related manufacturer report number 3006705815-2019-03111. It was reported that patient had symptoms of pain and discomfort at the implantable pulse generator (ipg) site due to the leads protruding out. Patient denied any falls, traumas or accidents. The device system was explanted as a result to resolve the issue. There were no complications during the procedure. Patient was stable.

 
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.

 
Event Description

Related manufacturer report number 3006705815-2019-03109. Related manufacturer report number 3006705815-2019-03111.

 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DeviceSCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8899068
MDR Text Key154542304
Report Number3006705815-2019-03110
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/16/2020
Device MODEL Number3186
Device LOT NumberA000058132
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/17/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/15/2019 Patient Sequence Number: 1
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