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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 Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problems Cyanosis (1798); Device Overstimulation of Tissue (1991); Cramp(s) /Muscle Spasm(s) (4521); Alteration in Body Temperature (4568); Insufficient Information (4580)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins). The reason for call was to address a therapy concern. Pt reported that the scs implant that the hcp "slapped in" is "big, black, bulky, and an enormous lump under their skin". Pt noted that they had to "access the chest port" going into surgery. Pt reported that the ins is "pulsing" and producing a "continuous wave of pulsation" that is causing the pt's feet to be cold and blue. Pt reported that the issues started yesterday, and the amount of sensation varies based upon the position of the pt. Pt reported if they roll over or stand up, the issue is "not continuous". Pt stated that when they left the hsp, the stimulation was set high.  pt stated they decreased stimulation to 5. 70v, but haven't been able to resolve the issue. Pt also reported that when they were in the hsp, the high stim was causing their legs to jolt, "like a frog in biology class". Pt noted they were sent home without any pain medication, and the ins site "looked like a piece of spam on their butt". Reviewed expectations of feeling stimulation. Walked the pt through turning the ins off, and the pt confirmed the issue went away. Had the pt decrease stim to 2. 25v and turn the ins back on. Pt increased stimulation to 3. 50v and confirmed they felt stimulation comfortably at the ins site. Pt noted they should feel stimulation in their legs. Reviewed the therapy, healing after surgery, and suggested follow up with the healthcare provider (hcp). Pt will follow-up with the hcp.
 
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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 Key11679506
MDR Text Key245819882
Report Number3004209178-2021-06172
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 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
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 Received04/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
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