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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Rn was consulted if patient was able to fill out screening form.Patient was deemed fit by nursing staff.Initial form was done in emergency department.Patient was now a candidate to send for with no contraindications for mri.Patient was brought to mri and questioned while being changed.No mri contraindicated implants noted by mri staff member.No obvious scars where observed during changing procedure.Patient was again screened before entering mri and signed screening form.Patient was reported to answer screening appropriately and even mentioned other surgical procedures they had received.Patient seemed by staff to be a good medical historian.Scan was started of the lumbar spine.It was not until the axial t1 scan that the technologist noticed a metallic artifact on mri.After discovered radiologist was consulted and immediately removed from scanner in proper fashion per hospital policy and documentation was done accordingly.Patient was again questioned about possible spinal cord stimulator and had no recollection of device being implanted.Patient was not able to give any information on where device was placed, manufacturer, date of impatient.Patient was monitored for possible adverse effects.None where reported by staff or patient.No additional treatments were needed per physicians/radiologist mrmd.Fda safety report id# (b)(4).
 
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Brand Name
SPINAL CORD STIMULATOR
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MDR Report Key11530847
MDR Text Key241570580
Report NumberMW5100140
Device Sequence Number1
Product Code LGW
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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