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

Model Number 37602

Device Problems Unintended Collision (1429); Low Battery (2584); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for dystonia and movement disorders.The patient reported that they never stopped trembling since the ins was put in.The patient reported that they fell 2 weeks ago and hurt themselves pretty bad and mentioned feeling light-headed.The patient reported they had not checked their ins with the patient programmer previously because they had a hard time finding and holding where they were supposed to put the programmer due to the tremors.The patient reported that after they fell, they thought the stimulation needed to be turned up and reported that the stimulation was turned up to 6.The patient reported that they could not walk or anything and they now wanted to turn the stimulation back down.The patient reported that when they tried to turn the stimulation down they couldn't because they saw an elective replacement indicator (eri).The patient reported trying to change the batteries in their patient programmer because they thought that would resolve the issue of the eri, but it did not.The patient reported that trying to sync the patient programmer with the ins during troubleshooting resulted in them seeing the poor communication screen 3 separate times.The patient reported changing the batteries again but still received the poor communication screen.No further patient complications have been reported as a result of this event.

• 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: 7534335
• MDR Text Key: 109031292
• Report Number: 3004209178-2018-11539
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/22/2018
• Date Device Manufactured: 06/16/2016
• 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: 70 YR