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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 1627487-2019-12754. It was reported patient was involved in a motor vehicle accident after having leads placed for a trial. Reportedly, the accident was due to the patient suffering a seizure. Patient has epilepsy. The trial leads were later removed.
 
Manufacturer Narrative
Device was returned and a visual inspection did not identify any anomalies. The device also passed functionality testing. Analysis did not identify a device problem. 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.
 
Manufacturer Narrative
The serial number, lot number, expiration date, udi, and manufacturing date have been obtained.
 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9345107
MDR Text Key167085488
Report Number1627487-2019-12755
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/17/2021
Device Model Number3186
Device Lot Number7023227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2019
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: 11/19/2019 Patient Sequence Number: 1
Treatment
SCS LEAD
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