MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; Stimulator, electrical, implanted, for essential tremor

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Shaking/Tremors (2515); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37642 lot# serial# unknown product type programmer, patient.Section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: unknown, ubd: , udi#: this regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient needed assistance charging their implant and after some clarification the patient was successful to use their equipment confirming seeing 8 black boxes on the bottom and the implant battery level was flashing between 50-75 percent.Patient stated they are shaking and have been for 2 days.Patient checked and said they did not think they saw a lightening bolt in the top left corner.Agent reviewed they can use the programmer to turn it back on.Patient tried to power up their programmer but stated the screen did not light up, they do not use the programmer very much.Agent reviewed the batteries should be replaced and once they are replaced they can call back for assistance to turn stimulation back on.Additional information received from the consumer reported they had been shaking for three weeks and their right hand shook all the time, and they had troubles recharging.The consumer called back 20 minutes later with a nurse who stated there were no coupling boxes filled in and there was some adhesive from the discs still on the recharger antenna.The consumer changed positions and was able to achieve 6 bars with the recharging showing the implant was 25% charged and therapy was off.It was reviewed to charge more and turn therapy on using the programmer.

• Brand Name: ACTIVA
• Type of Device: Stimulator, electrical, implanted, for essential 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18636978
• MDR Text Key: 334797877
• Report Number: 3004209178-2024-03448
• Device Sequence Number: 1
• Product Code: PJS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2023
• Date Device Manufactured: 04/19/2013
• 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
• Treatment: "SEE H10...."
• Patient Age: 94 YR
• Patient Sex: Female