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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97725
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 02/05/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacturing representative (rep) regarding a patient with a wireless neurostimulator (wens). Information was reported that the patient's trial started on february 4th and 12 hours later, around 2 am in the morning the patient had a severe seizure and she fell down. The patient's spouse took the patient to the hospital for treatment the following morning. The healthcare provider (hcp) asked the manufacturer representative (rep) to inquire if the seizure is associated with the patient having a trial. It was reviewed with the caller that the clinical summary doesn't have any data on seizures. The rep said the patient did have a preexisting condition with seizures, but that has been dormant for quite a while. The potential for stress of the spinal cord stimulator (scs) trial causing the seizures to come back. No further complications were reported. No additional patient symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was reported that the cause of the patient's was not determined. Patient went to hospital and monitored. It was unknown if the seizures had resolved. No other seizures have occurred to this point.  the serial number was not applicable, it was a trial. Patient's dob was provided. The provided information was confirmed with the physician/account.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9740672
MDR Text Key191098289
Report Number3007566237-2020-00281
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number97725
Device Catalogue Number97725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/21/2020 Patient Sequence Number: 1
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