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

Model Number 37603

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Malposition of Device (2616)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 10/29/2013

Event Type  Injury  

Event Description

It was reported that one unit ¿right generator, on the left side¿ was showing it had been off.It was noted that during that time the patient had had trouble going down hills.On (b)(6) 2013, the healthcare professional reprogrammed the implantable neurostimulator (ins), stimulation was set at 2.0v on the right generator on the left side.It was further noted that stimulation was set so that the patient's stimulation could be adjusted in the range of 0.0v-2.0v.The patient was not feeling well and had had ¿no sense of well-being.¿ it was further noted that the patient had not had the same feeling normally when stimulation was off.On sunday morning (b)(6) 2013 at about 9am, stimulation was turned on and lowered.When the right generator was turned on and they went to reprogram it and highlighted the voltage to lower it the patient responded ¿whoa! what did you do there?¿ the ins was turned off and interrogated.Stimulation was turned down to a tenth of the volt.Since sunday morning prior to this report, the patient had been doing a lot better.Programmer told them patient was off and patient was actually not off and turning at 2v.Patient did not have symptoms like she first had when stimulation was turned off because, she was on ¿carb levo.¿ 2v setting was ok but 24-48 hours later the patient did not like the setting.Stimulation was turned down.Additional information requested but had not been received as of the date of this report.Additional information received reported the healthcare professional was not adjusting the deep brain stimulator.Further follow up reported the cause of event was the patient had side effects to stimulation at all contacts.No abnormal impedances were noted.It was noted therapeutic settings had not been found despite multiple settings.It was noted an appointment was scheduled to have a representative assist with programming.Signs and symptoms associated with the event included dizziness, light headed and freezing.There was no hospitalization required due to the event and no injury to the patient.Additional information received reported the patient was scheduled for reprogramming on (b)(6) 2014.Additional information received reported the patient came in for reprogramming on (b)(6) 2014.It was noted that the patient was still doing poorly after being reprogrammed.Patient had an mri and the leads looked to be posterior and medial.It was noted that the patient may need to have a lead revision surgery.Nothing was scheduled at that time.The healthcare professional was going to discuss with another healthcare professional about the possibility of surgical intervention.Additional information reported that the patient was going to have a revision of the lead that is placed in their left hemisphere.It was noted, the health care professional thinks the lead is misplaced and the patient will be scheduled for revision.

Event Description

Additional information received reported, the patient was going to have a lead pulled from the brain on the day of report.It was noted they inquired what the concerns would be when it came to doing a magnetic resonance image (mri) with a lead cut at the extension site.It was noted, the patient had a loss of therapeutic effect.It was noted, the patient was having the lead removed due to lack of efficacy.It was stated, the doctor wanted to cut the lead and then go back into the patient in one month to finish the revision.

Manufacturer Narrative

Product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va01tfr, implanted: 2012 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3389s-40, lot# va0199g, implanted: 2012 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va01tfr, implanted: 2012 (b)(6); product type lead product id 3389s-40, lot# va0199g, implanted: 2012 (b)(6); product type lead product id 37603, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported there was not a 50% or greater symptom reduction.It was noted the patient never achieved efficacy and the cause of the event was not determined.The impedances were within normal range and the plan is to re-implant the leads.It was stated multiple reprogramming's were attempted but efficacy was never achieved.No troubleshooting or intervention had been taken to resolve the event and the mri was not related to the device therapy.The patient had been explanted.

• 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: 3604677
• MDR Text Key: 4095291
• Report Number: 3004209178-2014-01526
• 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,Followup,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2014
• Date Device Manufactured: 08/02/2012
• 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): Required Intervention
• Patient Age: 00070 YR