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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 PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problems Disconnection (1171); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Related manufacturer reference number 3006705815-2020-30781. It was reported that during an ipg replacement (related manufacturer reference number 1627487-2020-24061) on (b)(6) 2020, the physician noticed that one of the lead had migrated. It¿s unknown if the lead was accidentally pulled out during the procedure or the lead had migrated prior to the procedure. The physician opted to replace the lead. Effective therapy was restored post operatively. It's unknown which lead migrated, and both are being reported.

 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS 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 Key10438530
MDR Text Key203900083
Report Number3006705815-2020-30780
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 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/20/2019
Device MODEL Number3186
Device Catalogue Number3186
Device LOT NumberA000034687
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 Received08/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/20/2017
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: 08/21/2020 Patient Sequence Number: 1
Treatment
MODEL 3186, SCS LEAD
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