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Model Number 97714
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Patient Problems Edema (1820); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Weakness (2145); Complaint, Ill-Defined (2331); Electric Shock (2554)
Event Date 11/30/2016
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
On 2017-01-25, information was received from a manufacturer's representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for the treatment of failed back surgery syndrome and spinal pain. It was reported that since scs implant the patient has had chronic swelling and edema in legs that occurs with stimulation on, and subsides when stimulation is off. The nurse stated that it is called "pitting edema". The swelling is in both legs, but worse in the left leg and ankle. When the swelling subsides as stimulation turned off, it subsides faster in the right leg than in the left. The swelling never totally goes away to pre-implant level. They have ruled out that the patient has a vascular issue, that the patient has any issues associated with the patient's cardiac device and doesn't have any medical changes. The recharging and presence of the ins doesn't impact swelling according to the patient. The patient stated that they turn stimulation off when they recharge. They have tried using conventional and hd stimulation, cycling, electrode changes, but no reprogramming has resolved the issue. For example, with conventional stimulation use the patient felt good for a while, but then stimulation started to feel too strong and made the patients legs feel weak. The caller says that the patient has felt weakness in their legs with conventional and hd programming. The patient's wife tried turning stimulation off at night since the patient does not need stimulation, and the swelling would subside overnight , but it would return when stimulation was turned on the next day. Swelling has not been going away as much at night as it once was and swelling has become more chronic. The patient can't do as much as they could pre-implant because of edema and leg weakness. The patient is to follow-up with their healthcare provider (hcp). It was noted that they are trying a different reprogramming today, but the rep stated that it feels like they have exhausted those options. The patient has an appointment with the managing physician on (b)(6) and follow-up will be conducted at that time. The physician had ordered a vascular scan to check for clots and per ultrasound the vasculature is okay. No device allegations were made. On 2017-02-20 additional information was received from a patient via a manufacturing representative (rep) about a patient implanted on (b)(6) 2016. It was reported that at the patient¿s two week post-operative visit, the patient stated that the pain in their left hip was gone, but the pain in their back was not covered by the therapy. The patient¿s device was reprogrammed using ld and hd programs. It was reported that the representative met with the patient on (b)(6) 2016 to start adaptive stimulation (as) using the ld program and the patient expressed satisfaction. The patient called the rep on (b)(6) 2017 stating ¿this thing has gone crazy, i laid down and it kept jolting¿. The patient¿s wife told the rep that the patient was using the group activated for the as and that the voltage had indicated that it turned down. It was reported that patient had his wife to turn the stimulation off and they were wary of to turn it back on. The patient kept their stimulation off until their six week follow-up appointment on (b)(6) 2017. At that appointment the as was checked while the patient was in the upright and lying positions and it worked fine. The patient reported that they¿d rather use the conventional stimulation and turn it off at night, because they did not need it at night. They also told their doctor that they were having swelling in their left leg and slight swelling in their right leg. The patient¿s doctor did not attribute the swelling to the stimulator. It was reported that the patient had a history of cardiovascular disease, so ordered us leg vasculature. On 2017-feb-20, the patient contacted the rep stating that they had numerous cardiovascular and respiratory system tests done and they were all negative for problems, but the edema continued. It was reported that the edema increased when they used the stimulator, so they had not used it for two weeks. It was reported that the rep met with the patient repro and told the patient to use the stimulator again and if the edema increased then to turn it off. The patient had a follow-up appoint on (b)(6) 2017. It was reported that impedances were checked and every repro was within normal limits. On the (b)(6) 2017 follow-up appointment, the patient told their doctor that they had lost faith in the stimulator and was disgusted with the whole thing. It was requested that the device be explanted. An explant is planned but not yet scheduled. On 2017-03-09 additional information was received by the manufacturing representative (rep) reporting that the cause of the leg edema had not been determined, although the edema did decrease significantly when the patient turned their stimulator off and did not use it for days it was also reported that when the rep met with the patient on (b)(6) 2017, the had the patient "upright, laying it while using their programmer to check the voltage changes. " it was reported that the voltages decreased when the patient went from the upright position to laying, going from their left side to their back and from their back side to their right, etc. However, it was reported that they could not get the ins to mimic the jolting the patient had reported they felt. It was reported that communicating with the patient was somewhat challenging due to their age and they had minimal technical skills as well, so the rep talked with t he patient's wife as she makes all of the ins adjustments with the patient programmer (pp). The wife could not tell what the voltage reading was on the pp when the patient was being jolted as she was trying to turn the ins off as quickly as possible. The cause of the ins jolting was unknown.
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Manufacturer (Section D)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key6402331
MDR Text Key100683978
Report Number3004209178-2017-05542
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2017
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 Received01/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2016
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: 03/14/2017 Patient Sequence Number: 1