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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH SCS TRIAL LEAD Back to Search Results
Model Number 3086
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/21/2021
Event Type  Injury  
Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

 
Event Description

It was reported that the patient¿s trial on (b)(6) 2021 was aborted before placing the first lead due to excessive bleeding.

 
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Brand NameOCTRODE TRIAL LEAD KIT, 60CM LENGTH
Type of DeviceSCS TRIAL 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 Key11793691
MDR Text Key249969579
Report Number3006705815-2021-02175
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
Report Date 05/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3086
Device Catalogue Number3086
Device LOT NumberA000106880
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 Received04/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2021
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: 05/07/2021 Patient Sequence Number: 1
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