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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 LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3086
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Paralysis (1997); Numbness (2415)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Device 2 of 2. Reference mfr report: 3006705815-2019-01214. It was reported a successful trial procedure took place on (b)(6) 2019. During post-op, the patient reported feeling as if her legs were heavy and weak. As a result, the leads were pulled.
 
Event Description
Information provided in the medwatch report indicated that the patient had been sent to the hospital emergency room and had been admitted for approximately 7 days. Patient has been diagnosed with paralysis and left foot drop, chronic nerve pain peroneal nerve damage, numbness to right lower extremity, and weakness to both lower extremities. Follow up with the rep indicated that all imaging and neuro testing showed no indications for patient¿s symptoms.
 
Event Description
Reference mfr report: 3006705815-2019-01214.
 
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Brand NameOCTRODE TRIAL 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 Key8490112
MDR Text Key141163274
Report Number3006705815-2019-01215
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/19/2021
Device Model Number3086
Device Lot NumberA000075176
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 Received09/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2019
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: 04/08/2019 Patient Sequence Number: 1
Treatment
MODEL 3086, SCS LEAD
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