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

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product id 37612, serial/lot# (b)(4), implanted: (b)(6) 2021, product type implantable neurostimulator.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

Additional information was received from the patient that the handset still won't charge with the new usb-c charging cable.The end of the charging cable wouldn't fully insert into the handset indicating damage to the handset charging port.Pss emailed repair to send a replacement handset to the patient.The patient also alleged they were shaking, and when they went to charge their implants, "nothing happened." pss tried to start a charging session on the ins, but the patient accidentally disconnected the call.The patient called back and repeated information from the previous call regarding the return of symptoms (shaking), which resulted in them being unable to write and not eating very well.The patient believed the therapy was turned off, but they could not turn it back on because they could not access the dbs therapy app because the handset would not power on due to a (likely) damaged charging port.The agent reviewed that the handset replacement was expected to be delivered the next day.The agent saw in the previous follow-up note that the patient was having difficulty charging their inss, so they had the patient power on the wr and place it over one of the implants.The wr connected to one of the implants immediately, but then the wr power button started blinking orange and sounding an error tone a few seconds later.The agent had the patient reset the wr, which resolved that issue, and the patient could charge their implant without interruptions.The agent advised the patient to continue charging their implants, so they are sufficiently charged by the time they receive the replacement handset.The agent also reviewed that once the handset is paired with the communicator and each ins is linked to the handset, they will then be able to view the therapy status in the dbs therapy app and turn therapy back on (if it is turned off).The patient understood and said they would call back if they required further assistance.

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.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

Additional information received from the consumer reported the cause of therapy turning off was due to the batteries needing to be charged.The replacement devices resolved the neurostimulator charging issues and no further appointments were needed.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 15729555
• MDR Text Key: 307302506
• Report Number: 3004209178-2022-14416
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2023
• Date Device Manufactured: 07/30/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG