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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 Problems Hematoma (1884); Ambulation Difficulties (2544)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative

¿date of event¿ is estimated. During processing of this complaint, attempts were made to obtain complete event information. 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

Related manufacturer reference numbers: 3006705815-2021-04129. It was reported that during or after a trial implant procedure, the patient experienced a hematoma. The patient lost the ability to walk and control the bowels. As a result, the patient was hospitalized, the trial leads were removed earlier than originally planned on an unknown date, and surgery occurred during which a laminectomy was performed to remove the hematoma. The patient was discharged from the hospital and was prescribed physical therapy. The hematoma, inability to walk, and inability to control the bowels, have resolved.

 
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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 Key12351978
MDR Text Key267625096
Report Number3006705815-2021-04130
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 08/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2021
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 NumberA000109938
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 Received08/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2021
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: 08/22/2021 Patient Sequence Number: 1
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