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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 97714
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
Patient Problems Muscle Weakness (1967); Pain (1994); Burning Sensation (2146); Numbness (2415); Electric Shock (2554); Insufficient Information (4580)
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 non-malignant pain. The reason for call was pt reported that for about the last two years, they have had serious problems with their spine, mobility, and ins. Pt shared that they had been off health insurance for some time, and now recently got on health insurance again. Pt saw a surgeon recently and did an mri of their lumbar spine yesterday and now has to wait a few weeks for the results. Pt inquired whether mdt could do something in the meantime to check their ins and leads, as the pt suspects there may be something wrong. Pt said that it is painful for them to use the stimulator and painful for them not to use the stimulator. Pt said they aren't sure if they are helping or hurting themselves. Pt reported they feel excruciating pain from their mid-back down, burning and numbness to the bottom of their feet and toes; pt stated that because of this, they couldn't drive to hcp to get a pain injection. Pt said they have severe muscle wasting and it has gotten worse and worse. Last month, pt was attending physical therapy but lost control of their bowels the day after a therapy session, so they were removed from physical therapy. Pt was fearful that something bad has happened with their back and they do not want to be paralyzed. Pt mentioned they are getting a cervical mri in a couple weeks. Pss emailed field reps to contact the pt. Redirected caller: other (document in note) additional information received. Patient reported lumbar/cervical and thoracic mri is probably needed. Patient does know exact cause. Health care provider talking to patient about malfunctioning and probably needs to be replaced. Patient reported they've been fighting this issue for over 2 years. Issue not resolved. Patient reported needing help with stimulator before it paralyzes patient. Patient reported having mid spine down extreme pain, numbness and burning. Patient reported it was hurting them. Patient reported being electrocuted in heart/breast/ribs and belly.
 
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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 Key12416156
MDR Text Key271118695
Report Number3004209178-2021-13312
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 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2016
Device Model Number97714
Device Catalogue Number97714
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 Manufactured12/21/2015
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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