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

Model Number 37601

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515)

Event Date 08/01/2017

Event Type  malfunction  

Event Description

Information was received from a friend or family member of a patient with an implantable neurostimulator (ins) for essential tremor movement disorders.It was reported that the caller was having a lot of problems turning their ins on and off with the programmer.The patient has stopped turning it off at night because it is hard to turn back on.The caller clarified that they are able to connect to the ins and it reflects turning on and off on the programmer screen, but the patient continues to shake.The shaking has been occurring for about 3 or 4 days.The last time the patient¿s therapy was adjusted was probably 4 or 5 months prior.The patient was redirected to discuss the symptoms with their healthcare provider (hcp).Additional information was later received from a manufacturer representative (rep).It was reported that when the ins was turned on the patient would not get therapeutic benefit for hours or sometimes days.The issue has been ongoing for the past 6 months.The patient had left the ins on all the time because their tremor is severely debilitating without deep brain stimulation (dbs).The ins is able to turn off without issue.The issue was replicated in the clinic with two different patient programmers with and without an antenna.The programmer showed the ins was on, but the patient was not receiving benefit.A clinician programmer was used to sync with the ins, and each time the antenna was held over the ins and the sync button was selected the ins would turn on and the patient had immediate improvement in their tremor.This was replicated multiple times and the pattern was the same no matter how long it had been between using the clinician and patient programmer.Electrode and therapy impedances were normal and the ins had been implanted for 18 months.The physician nor the rep had not seen anything like it and had no thoughts as to why it was occurring.It was noted their best guess was some sort of software malfunction in the ins.The patient was instructed to keep the ins on for the time being, but this was not a long term solution as the patient has habituation to their settings.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6925208
• MDR Text Key: 89723613
• Report Number: 3004209178-2017-21210
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Date Device Manufactured: 01/21/2016
• 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 Age: 85 YR
• Patient Weight: 73