MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for essential tremor

Model Number 37602

Device Problem Insufficient Information (3190)

Patient Problems Shaking/Tremors (2515); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported that the patient's left implantable neurostimulator (ins) (b)(6) does not work.The patient explained that both of their hands were shaking, so 2-3 years ago their healthcare provider (hcp) moved both implanted wires to the right for the rechargeable ins (b)(6), and they disconnected the left ins.The left ins is still implanted.After the implanted wires were moved, the patient stated that it helped their shaking a little bit.The patient stated that they can move their right hand pretty well, but they cannot with their left hand, and they can do most everything they need to with their right hand.The patient stated that their hands still shake but they do pretty well.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their hcp to further address the issue.Additional information was received from the manufacturer representative (rep) that the patient was scheduled for a routine left eri ins replacement on (b)(6) 2023.Patient received a new ins at that time.It is unknown if this event is related to a previously reported event as the patient has cognitive decline and is not able to accurately state historical events.The patient received a new ins on the right when the previous battery was at eri and currently has a brand new ins on the left and.Both inss are functioning properly and patient is receiving therapeutic output and did not appear to have a tremor at the time of surgery.It is not known if the cognitive decline is related to the patient's dbs or underlying diagnosis.

Manufacturer Narrative

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.

• Brand Name: ACTIVA
• Type of Device: Stimulator, electrical, implanted, for essential 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17153928
• MDR Text Key: 317528659
• Report Number: 3004209178-2023-11223
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• 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: 06/19/2023

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: 12/14/2018
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Date Device Manufactured: 06/27/2017
• 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 Outcome(s): Required Intervention
• Patient Sex: Male