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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 97702
Device Problems Unintended Collision (1429); Energy Output Problem (1431)
Patient Problems Undesired Nerve Stimulation (1980); Scar Tissue (2060); Paresthesia (4421)
Event Date 08/12/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient stated they fell about a week and a half ago on a thursday and 2 days after that, they started to feel simulation where they don't usually feel stimulation; the patient described this as pulsating feelings in places they never had before. Patient said that they twisted when they fell, but they did not fall on their battery pack. Patient mentioned that they think they ripped scar tissue; patient services (pss) understood this as ripped scar tissue by the implant site. The patient said that they feel stimulation around the battery pack (implant), around the thigh and left cheek, and a little bit to the right and on top and that will pulse. The patient also mentioned feeling stimulation in their pinky and patient described the stimulation as pins and needles. Patient said that they noticed this when they were lying down 2 days after the fall and when this did not go away, they shut their simulation off and now they still have this going on for 4 days; pss understood this as the patient is still feeling simulation where they do not normally feel stimulation even with their simulation turned off. The patient said that they usually leave their stimulator on all the time, as they were told to, but rarely use the stimulator for pain because of their opioid medication and everything. The patient mentioned that they were raised up to a 50 from a 20 that they were usually on; patient was hard to follow at this point in the call but pss understood this as patient describing therapy settings they had.   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 Key12374018
MDR Text Key268364842
Report Number3004209178-2021-12976
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2018
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 Received08/23/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/06/2017
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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