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

Model Number 37603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Ambulation Difficulties (2544)

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3389s-28, lot# v532274, product type: lead.Product id: 3389s-28, lot# v532558, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 3389s-28, serial/lot #: (b)(4), ubd: (b)(6) 2013, udi#: (b)(4); product id: 3389s-28, serial/lot #: (b)(4), ubd: (b)(6)2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for movement disorders.It was reported that about a year ago, one of the electrodes went bad and stopped working, further stating that it was electrode 2 or 3.It was stated that patient could not walk well and when there was a picture of a doctor on the patient programmer (pp), it gave them a clue that something was wrong.It was stated that patient was having the same kind of problem with a relatively sudden onset.Prior to the report, the caller checked the implant and the pp showed on/ok.Patient was redirected to follow up with the health care professional (hcp) to have the device checked.No further patient complications were reported/ anticipated as a result of this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7529688
• MDR Text Key: 108785059
• Report Number: 3004209178-2018-11365
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2018
• Date Device Manufactured: 11/01/2012
• 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