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

Model Number 37612

Device Problems Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Shaking/Tremors (2515)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37085-60, serial# (b)(4), implanted: (b)(6) 2011.Product type: extension.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2011.Product type: extension.Other relevant device(s) are: product id: 37085-60, serial/lot #: (b)(4), ubd: 25-jan-2015, udi#: (b)(4) ; product id: 37085-60, serial/lot #: (b)(4) , ubd: 25-jan-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient with an implanted neurostimulator.It was reported that the patient has been experiencing a worsening of tremor when stimulation is increased.Patient thinks lifting heavy boxes and holding them against the chest at his job may be a factor that may have led or contributed to the issue.Troubleshooting was performed: impedance check was run multiple times with the patient holding arms, head, and neck in multiple positions.Impedance on contact 2 on the left was short (177 ohms).Patient saw the surgeon; they may have surgery to explore the extension and replace it.Additional information was received from a manufacturer representative (rep) reporting the cause of the impedance and tremor was not determined.No actions have been taken yet.The surgeon is exploring other non-deep brain stimulation related issues they believe the patient might have.The patient has not been into the office since the appointment where the impedance issue was discovered.They assume the impedance issue still exists at time of report; there is no plan to take action to resolve the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11219414
• MDR Text Key: 242424481
• Report Number: 3004209178-2021-01252
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Date Device Manufactured: 08/31/2015
• 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: 47 YR