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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 37602
Device Problem Device Operates Differently Than Expected
Event Date 07/11/2015
Event Type  Injury  
Event Description

It was reported the patient was admitted to the emergency room due to a loss of therapeutic benefit. The patient first noticed the loss of deep brain stimulation (dbs) benefit last night and today, the patient¿s arms and legs were moving wildly. The patient was brought to the emergency room by ambulance. Both of the patient¿s implantable neurostimulators (ins) were checked using the patient programmer and they were both on and at 3. 4v. Impedances were not checked. The patient indicated that prior to being taken to the emergency room, a nurse at their assisted living center may have made changes to their therapy, but they did not know what changes were made. The last reprogramming session was 3-4 months ago. The patient had no falls or trauma and had not been had any recent medical tests or environmental exposure. The reporter wanted to know if a manufacturing representative could check the inss. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389-40, lot# v000631, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient. Product id: 3389-40, lot# j0537580v, implanted: (b)(6) 2006, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. (b)(4).

 
Event Description

Additional information received from the healthcare professional reported troubleshooting performed included the patient presenting in the office for urgent follow-up on (b)(6) 2015 due to significant dyskinesia over the last several days and after an emergency room visit on (b)(6) 2015. No changes were made to the deep brain stimulator or parkinson's medications. The patient was treated with ativan with mild temporary relief. The patient had admitted that they had tried self-adjustments of the stimulator amplitude with the caregiver and dyskinesia was significantly worse. Actions/interventions to resolve the loss of effect included the patient being taken to a different emergency room on (b)(6) 2015. At the office visit on (b)(6) 2015 an interrogation was done and both batteries were ok, right settings were 1-2+, 60pw, 160 rate, 3. 4 amp and left settings were 1-3+, 60pw, 185 rate, 3. 4 amp. Right amplitude was decreased to 2. 8 with significant improvement of dyskinesia. Left amplitude was decreased on the left subthalamic nucleus (stn) to 2. 8 with resolution of the dyskinesia with right hand/leg tremor and the patient was increased back to 3. 2 with resolution of tremor and dyskinesia. The problem was not loss of effect but side effects, increased dyskinesia due to increased amplitude by the patient and caregiver. Dyskinesia resolved immediately when amplitude was decreased. The patient and daughter were provided written base settings along with reviewing how to self-adjust amplitude with the programmer and advised to call the office if there was any recurrent dyskinesia or any difficulty with the patient programmer. The amplitude range on the patient programmer was 0-3. 4. The patient had bilateral stn for parkinson铠disease.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4961817
Report Number3004209178-2015-14545
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/29/2012
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: 08/03/2015 Patient Sequence Number: 1
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