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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, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359); Cognitive Changes (2551)
Event Date 07/23/2014
Event Type  Injury  
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
Information was received from a patient who was implanted with a neurostimulator for spinal pain. It was reported that the patient had been attacked by an animal prior to implant and had his leg amputated. The patient had pain and got a rare disease and has been on a high level of pain medications. Starting in 2016, he began having severe pain which has been evolving, and the implant is not working on everything that it is set up to work on, including the legs. Recently, the patient got very sick and has a sciatica nerve problem. The sciatica was diagnosed on (b)(6) 2017. Additional information was received from a healthcare provider on (b)(6) 2017 which reported that the patient is having an mri and was admitted to the emergency room for back pain. They noted the patient was never given a programmer, and inquired if there was another way to put the device in mri mode. The caller was transferred to nas. It was reported by a consumer on (b)(6) 2017 that the patient needed a full body mri due to disk problems and pain under the scs ins and in their buttock area. The patient stated that the pain issues were unrelated to the scs. The pain started 2-3 weeks ago due to their sciatic nerve problem per the patient¿s health care professional (hcp). The patient also had an acute muscle infarction. It was mentioned that the scs was supposed to give stimulation below the waist but at times they felt stimulation from their shoulder down. The patient was not sure if the ¿bonus¿ stimulation was helping their pain of not. It was reported that the patient did have pain in their shoulder and neck down. It was asked but unknown when the patient started feeling stimulation in the shoulder. It was stated that patient services tried to help the patient put the scs in mri mode but the ins battery was depleted. The patient was going to recharge the implant and call back in order to put the scs into mri mode. Additional information was received from a consumer regarding the patient on (b)(6) 2017. It was reported that they were unsure what the circumstances were that led to the implant not working on everything. It was noted that the sciatic nerve problem is ¿about¿ a mri and the implant is in the way of the mri picture. The patient was working on getting the implant to work, as well as the sciatic nerve problem. The patient has been in the hospital many times for the excruciating pain in the back, legs, shoulders, and upper arms. The patient has felt the implant up to the shoulder and at other times, nothing.
 
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
The healthcare provider (hcp) reported the consumer needed an mri due to bilateral shoulder pain following a fall. Following the fall physical therapy was completed but it made the pain worse. The consumer thought the device was helping their right leg pain (which was the reason they were implanted) but they weren¿t sure because they had been taking pain medication since (b)(6) 2013. Additional information received on 2016-07-21 from the patient reported that they were expecting an mri on (b)(6) 2016 with the results the week after. Additional information was received from the consumer on (b)(6) 2017 reporting that the patient had been feeling stimulation off and on but had not thought much about it because they were in so much pain. The patient was able to turn stimulation up and down 2-3 times and felt comfortable but that was a while ago. It was confirmed that the patient had been able to charge since they fell. The patient tore both rotator cuffs due to a fall last year april that was because a pin in their prosthetic leg broke. The pin breaking, fall, and torn rotator cuffs were confirmed to be unrelated to the device or therapy. The prosthetic was due to the patient losing their right leg. The patient had been in a lot of pain which was why they got the ins. The patient had 2 rare diseases and was recently diagnosed with complex regional pain syndrome (crps). The patient had a hospital visit prior to implant and was now on heavy medications because their ¿brain was not good. ¿ the leg pain and pain all over had been since 2010. Additional information was received f rom the consumer on 2017-05-04 reporting that they were in excruciating pain. Additional information was received from a consumer via a manufacturer representative on 2017-05-15 reporting that the patient had a suicide attempt a few weeks ago to maybe a month ago. The patient informed the manufacturer representative who made sure that the health care professional (hcp) knew. The reason for the suicide attempt was the severe pain for the past 7 years. It was noted that the ins had been implanted for 3 years. It was unknown if there had been previous attempts. It was noted that the caller did not believe that it was device related. The patient was currently getting stimulation. No further complications were reported.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6376352
MDR Text Key102632262
Report Number3004209178-2017-04972
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2015
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 Received04/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/06/2014
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: 03/03/2017 Patient Sequence Number: 1
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