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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Fall (1848); Swelling (2091); Thrombosis (2100); Burning Sensation (2146); Dysphasia (2195); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported that the patient had the following symptoms: altered mental status, burning sensation, change in gait, difficulty walking, leg dragging and swelling.The patient¿s stimulation had to be turned up pretty high in order to control his tremor.Sometimes when it was so high he had a burning sensation in his face.When stimulation was turned off he still felt the burning sensation and he wanted to know if this was normal and if it was possible that it could cause permanent damage.When stimulation was turned off it took a couple of days for the burning to stop.The burning in the patient¿s face had started sometime in early to mid-(b)(6) 2014.There was a spot right about his lip that took longer to have the burning go away and sometimes it would take about a month before the burning stopped.The patient had two leads, one on the right and one on the left that were both connected to an one implantable neurostimulator (ins) which was in his left chest.The patient was told that in order to help with the progressive tremor and the burning in his face they would need to implant a 3rd lead and another ins in the other side chest and the patient was inquiring if this was normal.The patient¿s tremor was progressing and he was able to tell weekly because the tremor was moving and increasing.The patient¿s left hand was getting worse and he gait was also changing.Sometimes the patient had voice trouble, with tremor in his voice and sporadically he had uncontrollable tremor with his head and eye lids.The stimulation had worked at controlling his symptoms for a few months but the tremor had been gradually increasing so the patient was unsure if it was a stimulation issue or a symptom issue.Amplitude was set at 1.3 volts on the right side of the brain.The patient had a fall a couple of weeks prior to the date of this report, the patient stated that he had many ¿almost falls¿ but the last one was a couple of weeks prior to the date of this report.It was noted that it had been a nightmare since day one.The patient stated that when the leads were put in the brain he had an edema of the brain and they were not sure what the swelling was from but the patient had brain damage from the swelling.After the implant they had brain swelling.The patient had blood clots from being down for so long.Also, the patient was unable to use the right side of his body for a few days after the surgery.The patient zoned out, the nurse would bring the patient into a dark room and he would not be able to figure out what he was supposed to do until he was directed to turn on the light.The patient had stated that it was like he knew what to do but would get stuck in between what he should do and how to do it.On occasion he would have to use the left hand to move the right hand and also he would want to use his right hand but he wouldn¿t know how to use it.The patient was able to walk normal but sometimes his leg would drag.Most of the time it was the left leg that would drag but it would also be the right as well but the left was worse.Following implant of the leads the patient was already having problems before he even got home.It was so bad that his wife brought him to the emergency room.It was noted that while at the emergency room the patient was so thirsty, he got up and walked over to the faucet; he could hear the water gurgling in the pipes but forgot to turn on the water so he was trying to suck the water out of the faucet.The patient would drift in and out of reality.The patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative.The patient had an appointment scheduled but the date was illegible.No outcome or intervention was reported.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va0btky, implanted: (b)(6) 2013, product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, 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 Key: 4515835
• MDR Text Key: 5488201
• Report Number: 3004209178-2015-02968
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2015
• Date Device Manufactured: 10/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00050 YR