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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Operates Differently Than Expected (2913)
Patient Problems Nerve Damage (1979); Device Overstimulation of Tissue (1991); Pain (1994); Thrombosis (2100); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. It was reported they were on blood thinner because they had a clot in the leg. The patient was given a shot in the back and this did help some with the pain. They went back to their healthcare provider last week because the pain was a little better but was still intense across the back. The patient stated that stimulator hasn¿t stimulated or helped in some time. The patient states there was a discussion that they will try injections and they might have to move the wires. The patient¿s weight was (b)(6). No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A patient reported he continues to be in severe pain, despite the implantable neurostimulator (ins) have been programmed multiple times. The patient had physical therapy and acupuncture done. The patient was taking pain medication. The patient met with the manufacturer representative last week. The patient further reported he had a lamectomy (laminectomy?) on the right side in (b)(6) 2017 because of his ongoing pain and problems. The patient indicated his nerve was severely damaged and he was not able to walk after the spine surgery due to the pain. The patient also had a blood clot in his right leg in either (b)(6) 2017. The patient continues to be in constant pain from the small of his back and right hip to his buttocks. The patient mentioned that the ins worked well to relieve his pain before the leads migrated together. The patient stated that last week he used group b on the right side and was told to turn it up to ¿500. ¿ the patient indicated the stimulation felt intense at ¿440¿ but he kept it there for a while. Additional healthcare provider listings were sent to the patient. Acupuncture compatibility recommendations were reviewed. The indication for implant was spinal pain.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6645547
MDR Text Key101604984
Report Number3004209178-2017-13008
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,Followup,Followup,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2014
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2013
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: 06/15/2017 Patient Sequence Number: 1
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