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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Erosion (2075)
Event Date 06/04/2021
Event Type  Injury  
Manufacturer Narrative

Date of event and therapy date are estimated. The results/ method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference number: 3006705815-2021-03104. It was reported that the patient's lead became exposed through the skin. As a result, surgery occurred to explant the leads to address the issue.

 
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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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12057836
MDR Text Key258051692
Report Number3006705815-2021-03103
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/10/2020
Device MODEL Number3186
Device Catalogue Number3186
Device LOT NumberA000067293
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 Received08/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2018
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: 06/24/2021 Patient Sequence Number: 1
Treatment
SCS LEAD
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