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

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.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, 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 Key: 11679506
• MDR Text Key: 245819882
• Report Number: 3004209178-2021-06172
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR