MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, implanted: (b)(6) 2011, product type: lead.Product id: neu_unknown_lead, product type: lead.(b)(4).

Event Description

A healthcare professional from a clinical study for obsessive compulsive disorder (ocd) reported the patient had received a double implant involving the subthalamic nucleus (stn) and nucleus accumbens.It had appeared that the stimulation of the nucleus accumbens had had a positive effect on her personality but not on the ocd.Stimulation of the stn improved the ocd through the right stimulation electrode.The left stimulation electrode was positioned too far in the center and did not provide therapeutic effect.There was some improvement in the patient.A right stn electrode stimulation had resulted in its increased impedance.There was a known lead dysfunction of one of the stn leads.There was an increase in right lead impedance and a decrease in clinical outcomes.Diagnostics included several reprogramming trials, after having tried all possible combinations of the right electrode the clinical status had deteriorated.It was unknown what had led to the event.It was decided to perform a bilateral re-implantation of the stn, to replace the right electrode and better position the left electrode.During the surgery the trace from the internal electrode was poor, it was decided to implant the permanent electrode in a central position.Multiple checks had identified a slight 1 mm internal deviation to the right electrode, despite repositioning using the permanent guide tube.After 3 attempts it was decided to leave in that position due to the risks from the re-implantation.The device was explanted and re-implanted.The event had required admission or extension of hospital stay from (b)(6) 2015.According to the investigator the serious adverse event appeared most likely related to the medical device, there was a certain relationship determined.The issue was resolved.The serious adverse effect was noted to be expected.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5483411
• MDR Text Key: 39771118
• Report Number: 3007566237-2016-01292
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 00041 YR