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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 97702
Device Problems Overheating of Device (1437); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fall (1848); Bone Fracture(s) (1870); Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Electric Shock (2554); Alteration In Body Temperature (2682); Hydrocephalus (3272); Constipation (3274)
Event Date 06/10/2016
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 a consumer via a manufacturer representative (rep). The patient's wife reported the patient was still experiencing an occasional shocking sensation in an unspecified location. The patient reported pain at the battery site due to the placement of the device. The patient's wife described the patient had a "keloid scar. " the patient was considering explant, but was unsure at the time. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacture representative (rep) via the patient¿s family member on 2018-apr-06. The patient¿s family member stated that the patient had the system explanted. The hospital analyzed the battery. Per the reports, it was bad when it went in and bad when it came out. The patient had symptoms of ¿water on the brain¿ that the patient was experiencing due to the device. The patient¿s family member was told to call patient services. The patient¿s family member called patient services indicating that the device was explanted due to it causing water on the brain. It was discovered that the device was implanted with a bad battery. This was confirmed when it was explanted. It was causing them trouble for a year and a half. The caller spoke with patient services again indicating that the implant was no good to start with but everyone thought the patient had water on the brain. The patient was having problems with wetting the bed, they were confused, could not walk right, and were falling. The patient had a ct scan to check for water on the brain. It came back negative. The healthcare professional (hcp) confirmed that the issues were from the implant. The machine was removed and tested. The results came back that the machine was bad. The event date was noted to be since implant. The call was disconnected so patient services called the patient¿s family member back and left a voicemail. The caller called back stating that the implant was put in wrong. The hcp put it in a bad spot that did not have a lot of fat so it hurt and the patient was always sitting or laying on it. When the patient fell they broke their ribs and collar bone. The patient started falling 2 weeks after implant. It was noted that the patient was falling, their bones were breaking, their head and feet would not walk together, and they had pain at the implant site. Ever since the implant was removed, their symptoms went away. The ins was removed (b)(6) 2017. It caused the patient so many issues. No further complications were reported/are anticipated.
 
Manufacturer Narrative
Date of event was reported as approximately 6 weeks ago.
 
Event Description
Information from the patient via the manufacturer's representative reported that the implantable neurostimulator (ins) caused them not to move their left lower extremity while on the stairs and, as a result, they fell down the stairs and fractured their right clavicle. This occurred approximately 6 weeks ago. The patient also reported that prior to the fall "this thing (scs system) had me all screwed up" stating that it affected their entire body including affecting his speech. In addition it was reported that it affected the patient's ability to walk before the fall event. The patient and their spouse reported that until yesterday that the spouse performed all the adjustments with the patient programmer. When it was asked what the amplitude was at the time of the fall, the spouse stated that it was unknown but did mention it was no greater than 5. 0 volts and stated that "i have to shock him from time to time". Reprogramming was performed today and, at the patient's request, the program that stimulates the left lower extremity was deleted leaving only a program for the right lower extremity. The patient stated that after the reprogramming that "finally someone fixed this thing". No surgical interventions occurred or were planned. The patient status at the time of report was noted as "alive - no injury". The issue was reported as resolved at the time of report. The indications for use for the implanted device were noted as failed back surgery syndrome and spinal pain. Relevant medical history included chronic low back and leg pain.
 
Manufacturer Narrative
(b)(4). Please note that an earlier date of first onset of the event was reported.
 
Event Description
Additional information was received from the patient. It was reported that the patient had pain at the ins site since implant. The patient had difficulty walking because of the pain at the ins site. It was noted that the patient saw his primary care physician on (b)(6) 2016. The patient was to follow-up with a healthcare professional. It was noted that he change in therapy/symptoms was gradual. Additional information was received from a consumer. It was reported that the patient also was falling. The consumer thought the size of the ins might be contributing. Additional information was received from a manufacturer representative (rep). It was reported that a number of rep had spoken with the consumer multiple times. There was no issue with the device and the patient and consumer were encouraged to follow-up with one to the healthcare professionals involved with the device. The rep noted that until the patient makes an appointment with a provider there was nothing the reps could do.
 
Event Description
Additional information was received from consumer. It was reported that the patient had pain in his legs with the ins was turned on. When the ins is turned off, the patient did not have pain in his legs. The caller also reported it hurts the patient's back. The patient is not walking around very well and is in therapy, but the patient is not walking nearly as well as he did before and the patient does not want to turn the ins back on due to the reported issues. The patient was redirected to their managing healthcare provider and a list of providers was sent to the caller.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information received from the consumer reported that the patient had nothing but trouble with their ins. The ins had been hurting the patient since implant. It was noted that the patient¿s mind was not ¿straight with this¿. The consumer reported that, 2 weeks after the implant surgery, the patient had to travel to the healthcare professional (hcp) appointment in a wheel chair and every month the patient was getting worse. The patient had been falling (multiple falls) and one time broke their collar bone. In addition, the patient was suffering from ¿water on the brain¿. The patient felt electrical shocks, complained ¿it was hot¿ and that it hurt. The patient turned the therapy on in (b)(6) and the ins stopped hurting them. However, the patient kept complaining of it ¿being cold¿ but the ¿electric stopped¿ hurting them. Even with the therapy off it was still hurting the patient. The consumer stated that "the minute it stopped hurting him" after it was shut off, "it was still doing this¿. It was noted that the patient had started to get better and about 75% of all this had stopped but they still experienced issues with their brain. The consumer reported something about when the patient was in the ¿manor¿ they were walking and talking but not thinking due to ¿water on the brain¿ which was being addressed now by the hcp. The reporter mentioned that they had spoken to the manufacturer¿s representative and had been working with their healthcare professional (hcp). The reporter stated the representative indicated the therapy was off and should not be hurting the patient. The reporter was going to follow up with the hcp.
 
Event Description
When contacted for follow up information, the healthcare professional (hcp) reported that they had not seen the patient since (b)(6) 2016 and noted that there was no report of the patient¿s issue at their office.
 
Event Description
Information was received from a patient¿s family/friend to a manufacturing representative about a patient implanted with a neurostimulator for failed back surgery syndrome and spinal pain. It was reported the patient was in the office on (b)(6) 2016. It was reported that they had not been using their ins at all, as the patient¿s family member reported that after the patient was implanted they developed gait disturbances, altered mental status, along with difficulty speaking. It was also reported that the patient had a couple of transient ischemic attacks (tias) not long after being implanted, which were unknown at the time whether they were related to the device/therapy. The patient was reprogrammed at this time and the stimulator was turned back on. The patient ¿jumped up-and-down,¿ ecstatic to have stimulation back on and covering where they needed it. Impedances were within normal limits. The manufacturing representative then reported that the patient¿s family member continued to contact them multiple times a day, following their meeting on (b)(6). It was then reported that the patient was in the hospital after a fall and was still confused and having the same issues as reported earlier. It was reported that the device again had not been on and was turned off almost immediately after they met on (b)(6). It was also reported that the patient was not oriented and the family member was doing all the speaking for the patient. Another report from the family member came in reporting that the patient stated that the stimulator was hot and then got cold, while the ins was off. However, when the family member was asked if the skin around the ins or if the ins site was hot they replied ¿no¿. It was alleged that the patient was crazy and losing their mind and really confused due to the device. It was most recently reported, that the patient was in the emergency room and it was suspicious that they had hydrocephalus. A computerized tomography (ct) scan was done and the hydrocephalus diagnosis was undetermined but a ct scan of the patient¿s abdomen found the patient to be extremely constipated. Multiple rounds of enemas were given to help the constipation. After this it was stated that the patient started to get better and walk a little better. The representative explained constipation can cause confusion, but the family member stated it was all due to the stimulator. In the last call, the family reported that the physician told them the patient¿s battery was ¿overloaded,¿ and the family member was recommended to contact patient services. It was reported that the patient wanted their ins removed. It was reported that they had not had it on since they were seen in early (b)(6). It was reported that when the stimulator was on it felt like it was shocking or ¿biting¿ the patient¿s leg, causing them to fall; they elaborated saying the stimulation was too strong. When the stimulator was off, it was reported that the patient¿s gait improved. It was reported that the patient did not turn stimulator intensity down when this occurred but instead just turned it off. The manufacture representative found that the ins was on, but the amplitude was a 0. 0v. Interrogation of the battery demonstrated that since (b)(6) 2016 the battery was on 100% of the time. Impedances were within normal limits at all contacts. The manufacturing representative turned stimulator amplitude up to test what the patient felt and it was reported that the patient stated they felt great and it covered their painful areas completely. Program parameters were not changed, the amplitude was just increased on the existing program a until the patient indicated they were comfortable. The representative reported educating the patient how they did this and how to adjust positional changes as well. The patient stated that they understood and ¿just want it to work¿. The patient sta ted that they had said this in the past to another manufacturing representative and the present representative reported that they recall them saying something similar to them when they saw the patient months ago. It was reported that the healthcare professional was present so the manufacture representative and the patient and their wife discussed keeping the stimulator in moving forward or having it explanted. The patient and their wife decided to try the stimulator and control it as discussed. Throughout the appointment, the patient and his wife reported and recounted the patient's many medical problems over the past few months, including tia and suspected hydrocephalus. The patient's wife thought they were all related to the stimulator but did not provide details as to how she believed this to be the case. Additional information was received from a manufacturing representative reporting that they had a conversation with the patient¿s physician and witnessed a conversation the physician had with the patient stating that the tia was not related to the patient¿s device/therapy.
 
Event Description
Additional information was received from a manufacturing representative reporting that they had a conversation with the patient¿s physician and witnessed a conversation they had with the patient stating that the tia was not related to the patient¿s device/therapy. Additional information was received from the patient through a manufacturer representative. The patient's spouse reported that the battery "should have been recalled. " it was reported that the device had shocked the patient over and over even when it was set to 0v. The patient's spouse stated that "the fda had warning on all the serial numbers but not every model #. " they also stated that some had a bad lead that caused symptoms like "water on the brain" and stated that this lead "made the stimulation double or triple. " the patient's spouse did not understand how the device went from bad to good between (b)(6). No further complications are anticipated.
 
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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 Key5996279
MDR Text Key101629956
Report Number3004209178-2016-20334
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,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2017
Device Model Number97702
Device Catalogue Number97702
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 Received04/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/14/2016
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: 10/04/2016 Patient Sequence Number: 1
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