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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problem Device Operates Differently Than Expected
Event Date 06/13/2014
Event Type  Injury  
Event Description

It was reported that the patient had had balance issues and trouble with speech since implant. It was noted that the patient had fallen a couple of times. Initially it was thought that the patient¿s medication was off but he had been off the medication and was still having problems. Patient had been instructed to turn stimulation down and had further programming appointment scheduled for the friday following the date of this report. Patient¿s stimulation was down from 3. 30 and 4. 10 to 3. 0 and 3. 40. Patient¿s status was unknown. It was later reported that there was disappointment and dissatisfaction expressed about the therapy as far as what had been sold and presented to them prior to implant and what had happened in reality. Patient had tremors prior to the deep brain stimulator implant. Patient had been pretested and it had worked for him. Almost 2 months after implant the patient had a lot of issues. Patient¿s quality of life had not increased. Patient had an appointment scheduled for (b)(6) 2014. Patient was experiencing symptoms. It was noted that the patient had expected it to be an outpatient surgery and instead patient had spent 10 days in rehab. The patient had been told about the risk of infection and stroke but nothing else. The patient had been trained on using the patient programmer but did not know what to do with it. The patient was not very discouraged and not positive. The patient was not enjoying things in life anymore. It was noted that prior to deep brain stimulator surgery the patient had only had some tremors and had not been that advanced with parkinson¿s disease symptoms. The deep brain stimulator surgery was supposed to make the patient better but had made him worse. Patient was not able to return to his physical job. Patient¿s symptoms were change in gait, lethargy, and seizures. It was further noted that the manufacturing representative had been there when the patient had a seizure and the representative had come to rehab. The patient had had a seizure right after surgery at the hospital on the date of implant. At rehab the patient had been completely out of it and had been unresponsive. The healthcare professionals were blaming it on medications. Patient was put on 4 different seizure medications, one being dilantin. Patient no longer took seizure medication. Patient was unresponsive and was sent for a computerized tomography scan (cat scan) which had determined the patient had seizures and that was when patient was put on seizure medications. The healthcare professionals had stated ¿oh no, he should be responsive. ¿ it was noted that nobody seemed to know what was going on. They had come for physical therapy and were not able to wake him up, he had been completely out of it. An electroencephalogram (eeg) was done and had not found anything particular. Following deep brain stimulator surgery patient had the following symptoms: speech issues, gait issues, balance problems, patient had fallen several times, extremely tired, swallowing issues, patient looked at food as if he did not know how to put a fork into it, and patient looked like he had aged (b)(6). Patient used to work full time, go to ymca 3 times a week and drove a car, patient was no longer able to drive or do anything. It was hard to leave the patient alone. It was believed that symptoms were device related because patient had no chemicals in his body except some medication for parkinson¿s and it was not a lot. Healthcare professionals stated they had never seen those symptoms after a deep brain stimulator surgery. Patient was told that this kind of reaction was very common and it might take 6 months to a year to recover from the surgery. Patient had been given a limit on the patient programmer and could not go beyond ¿4 or something. ¿ patient had been adjusting therapy all the time on his own. Patient got better here and there but still had a lot of issues going on and was no longer positive. Patient was scheduled to see the healthcare professional on friday following the date of this report. Additional information received reported the patient was having some gait and speech issues related to programming. Patient had primary tremor with parkinson¿s and as the patient would get tremor control he would get some speech issues. The patient had since been reprogrammed to a bipolar setting and although he had a little bit of a breakthrough tremor his balance was better and so was his speech the last time the manufacturing representative had spoken to the patient. It was unknown if there were any other updates. The manufacturing representative had been involved with the patient through rehab. It was noted that the patient¿s family was anxious about getting the patient¿s progress and getting him programmed so he could go back to work. As of the week prior to the date of this report the patient was doing better and was planning on returning to work. Additional information received reported the alleged seizure was not the reason for rehab and all of their patient¿s go through a rehab cycle. Seizure was not confirmed and had been discussed after the fact. The patient was having some cognitive issues after the battery placement that had led the healthcare professional to believe it may have been a seizure. Patient had been placed on seizure medication and had not had any seizure activity after the first alleged one. Additional information was requested but had not been received as of the date of this report.

 
Event Description

Additional information received reported the manufacturing representative was not made aware of alleged seizure until the patient¿s wife had mentioned it while in the clinic for normal programming. The manufacturing representative was not in the operating room and had had no knowledge of the alleged seizure. The wife had told the manufacturing representative that the patient was done taking seizure medications and inquired if programming would cause problems. Patient was doing well with reduced tremor as far as the manufacturing representative knew. The manufacturing representative had only seen the patient twice, once while in rehab and once in the office.

 
Event Description

Additional information received reported the patient had been admitted to rehab for programming which was a typical pathway. This was following the placement of the implantable neurostimulator (ins). The manufacturing representative had not been in communication with the surgeon about the possible seizure that had been treated prior to hospital discharge. The manufacturing representative was involved with programming. The manufacturing representative had not been aware of seizures but there had been a reduction in seizure medication following surgery. The patient was doing great as of about a week and a half prior to (b)(6) 2014. Additional information was requested but had not been received as of the date of this report.

 
Event Description

Additional information was received from the patient. The patient stated the therapy had never helped with his parkinson's symptoms and noted the therapy gave him more problems including affecting his speech and balance. The patient reported he fell over a lot and mentioned he was in a wheelchair. The patient reported the healthcare professional was trying to reprogram the therapy. The patient also mentioned something about an mri and something "being in the wrong place" but was unable to clarify the issue.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3389s-40, lot # va0jcu8, implanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708695, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-40, lot # va0jcu8, implanted: (b)(6) 2014, product type lead.

 
Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jcu8, implanted: (b)(6) 2014, product type: lead. (b)(4).

 
Manufacturer Narrative

Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3389s-40; lot # va0jcu8, implanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708695, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-40, lot # va0jcu8, implanted: (b)(6) 2014, product type lead.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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 NEUROMODULATION
road 31, km. 24, hm 4
ceiba norte industrial park
minneapolis MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263920
MDR Report Key3979081
Report Number3004209178-2014-13934
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/28/2014
Device MODEL Number37603
Device Catalogue Number37603
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 Received05/29/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/09/2013
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: 08/05/2014 Patient Sequence Number: 1
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