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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that  every time patient has an mri scan when patient turns therapy back on their adaptive stim does not show programming for "laying down" patient confirmed it will show all the other positions set but when he tries laying down the screen shows "upright" additional information was received. It was reported the patient would be out of town for two weeks and would call to schedule an appointment when they got back. Caller met with patient(pt) today for routine reprogramming and pt mentioned that pt had just had an mri scan earlier in the day and that pt loses his adaptive stim (as) settings every time the pt has an mri which occurred again today. When caller interrogated ins (after mri had occurred), caller found that pt's as settings were still present but that as was turned off and the resume was set to off. Pt says this has occurred every time after he has had an mri scan starting some time in 2020. These are unrelated mri scans. When this occurs for pt, the pt notices that as its turned off and pt has to reenable as and redefine all of his positions manually using pp. Caller recreated this situation today with pt in that caller set up as settings for pt using tablet and then had pt put ins into mri mode using pp. Then they took ins out of mri mode using pp and then as was showing as off on pp. Tss was unable to explain this as that shouldn't occur.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11543751
MDR Text Key241531330
Report Number3004209178-2021-04678
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model Number97714
Device Catalogue Number97714
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 Received03/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/29/2017
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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