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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Event Type  Injury  
Event Description

Additional information received reported that the device had not worked for the patient since implant and he had had really bad side effects with it. The surgeon agreed to remove the implantable neurostimulator (ins) and leads ¿in a few weeks. ¿ two weeks later it was reported that the entire system was explanted.

 
Event Description

It was reported that when the patient had woken up in recovery on (b)(6) 2014 after the deep brain stimulator implant they had vision, balance and speech problems on their right side. The patient had nothing but problems with the left implantable neurostimulator (ins). The side that controlled the patient¿s left arm worked well in controlling the tremors, but the side the controlled the right arm was giving him trouble. The patient could not move his eyes which contributed to his movement and instability problems. The patient was also agitated and weak and used a walker. The patient used a walker full time now and they were not doing well. Two years prior to this report the patient was very active and they could not do anything at the time of this report. When the patient¿s right side was turned on the reporter could not understand what the patient was saying. The patient was looking into having the inss removed. The patient had spoken to their healthcare professional (hcp) who thought they could take the ins out and leave the wires and electrodes in place, but they did not want to do that. The patient¿s vision, balance, and speech were affected in the recovery room after implant and the hcp stated they had problems finding a spot that it would not affect. The patient did not have any problems going into surgery. In the recovery room the patient¿s speech was altered and their eyes were fixed at the ceiling so a ct scan was ordered because the hcp thought the patient had a stroke. In (b)(6) the patient went back to their hcp and they tried reprogramming five times, but the patient¿s symptoms got worse. The patient waited for the swelling to go down and the symptoms to resolve, but it¿s now december and the patient still had problems. The reporter thought the wires and electrodes caused the problem and removing them did not guarantee the problem would go away. The reporter stated the hcp told them they had to do more than one tunnel to find the right spot. The reporter further stated they wanted to know why the patient could not have all of the leads taken out. The hcp stated they were willing to remove the ins in about three weeks after this report. 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

(b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4326957
Report Number3004209178-2014-23891
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/14/2015
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/09/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/16/2014
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: 12/12/2014 Patient Sequence Number: 1
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