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

Model Number 37601

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that there was a loss of therapeutic effect.Patient was implanted with the deep brain stimulator about 3 years prior to the date of this report.The patient was quickly going back to shaking like prior to implant.The patient had been falling, dropping things and shaking lightly which had started about 3-4 months prior to the date of this report.It was noted that it had gradually gotten worse and worse and then the patient had started falling.On friday prior to the date of this report, the patient had fallen twice and he could not get up and was unable to get inside which was the worst he had fallen.The patient hurt his back and he had laid there for 3 hours.Since sometime towards to the end of (b)(6), the patient¿s shaking had gotten a little worse and he was unable to hold a glass in his left hand.It was noted that it appeared he would have a new implant sometime in (b)(6), as they were trying to get him in for surgery because ¿this thing was getting worse and worse.¿ the patient had never turned his stimulation off before.The patient was unable to adjust stimulation after his granddaughter got a hold of his programmer and turned his stimulation down to 0 volts on 1 side, and he was now unable to turn it back up again.When the patient would try and increase stimulation, he would get an information screen but was unable to describe the exact picture on the screen.During the phone call the patient ended up adjusting something and was now able to increase the stimulation and was at 5.3 volts on the left side and 4.10 volts on the right, and the issue was resolved.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

Product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v833497, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v779188, implanted: 2011 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient.(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: 4089335
• MDR Text Key: 4745447
• Report Number: 3004209178-2014-17017
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Date Device Manufactured: 10/08/2011
• 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