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Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction  
Event Description

It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

Manufacturer Narrative

Concomitant products: product id 3387-40, lot # v002945, implanted: (b)(6) 2006, product type lead; product id 3387-40, lot # v002945, implanted: (b)(6) 2006, product type lead; product id 748266, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 748266, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 64002, lot # n292028, implanted: (b)(6) 2012, product type adapter. (b)(4).

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Brand NameACTIVA
Manufacturer (Section D)
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
chad hedlund
7000 central avenue ne rcw215
minneapolis , MN 55432
MDR Report Key3530979
Report Number3004209178-2013-23849
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/28/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Date Manufacturer Received12/12/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/11/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial