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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97713
Device Problems Energy Output Problem (1431); Overheating of Device (1437); Electromagnetic Compatibility Problem (2927)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that about a week ago the patient was lying in their bed and felt sudden excruciating pain that felt like their intensity was turned up extremely high (about 5 to 10 times higher than the patient ever had). The patient also felt intense internal heat. The patient walked around their townhouse for 5-10 minutes and the feelings continued and they went outside and the sensations faded. The patient spent the night at a hotel and didn't have the sensations but went home the next day and the sensations returned. The patient thinks their neighbor (who did "extraordinary" things to the patient and other neighbors in the past) caused the sensations with some type of high emi device. Patient services specialist reviewed possible effects that high levels of emi could have on a spinal cord stimulator. The patient denied any recent injuries/traumas. After this situation happened the patient moved out of their townhouse and they have a new pain in the area where the intense pain was. The patient turned their spinal cord stimulator off about a year ago but denied any complications with their medtronic device. The patient has not attempted to connect their external equipment to their ins. The patient needs to have a mri and plans on having their spinal cord stimulator removed so they can have a mri (patient made no allegations against medtronic device). The patient was redirected to their healthcare provider to further address the issue.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12094569
MDR Text Key259265246
Report Number3004209178-2021-10198
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2015
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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