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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 97702
Device Problems Intermittent Continuity (1121); Energy Output Problem (1431)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Insufficient Information (4580)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97702, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported to a manufacturer representative that that unprompted, 3 weeks ago she was running stim as she normally does and then she felt it go higher than normal--the pt was sleeping and woke up to this sensation. The patient described it as "it was just like it was frying" her and it hurt really bad; pt stated that she woke up in the morning and she couldn't even get to her controller, so her husband had to get the controller and shut it off. The pt has a thoracic and cervical system. Pt turned thoracic device down and it did not resolve, still felt like strong stim everywhere. Pt turned thoracic stim off and it did resolve the lower body but the pt was still feeling very strong in upper and then shut that off and everything went away. Caller states they then turned both devices back on after a couple days at half the previous voltage. She couldn't turn it up to her normal level because the stim sensation was still too much. It happened one more time after that and it wasn't nearly as bad. The manufacturer representative check ed cervical impedances and said they were 500-800ohms across the board. Possible causes of what may have caused this were discussed - emi, possible migration (though unlikely if this occurred out of no where for both systems). The patient was instructed to keep track if this occurs again (keep a log of date, activity, etc. ).
 
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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 Key11711705
MDR Text Key267513608
Report Number3004209178-2021-06485
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
Report Date 04/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/05/2018
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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