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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); No Device Output (1435)

Patient Problem Shaking/Tremors (2515)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that the caller said they didn't know if the dbs implant was working because for about the last 4 months, the patient had been having a return of dbs symptoms.The patient was currently shaking, the leg shakes, the medication (levodopa) hardly does anything.Caller said patient had been able to cut down the medication intake to about 2 medications a day that gave patient their energy back for about 3 or 4 hours but now patient could take 5 medications a day that only last about 2 hours.Caller said implant battery was charged to 75% but the implant wasn't preventing the shaking.The caller didn't know why dbs symptoms had returned.During call patient was recharging and recharging app showed implant at 100% and therapy off.The call agent attempted to walk caller through turning on therapy but was unsuccessful due to issue with communicator and handset.When attempting to enter my dbs therapy a pp, caller would get the pick communicator screen, caller would choose the communicator and kept getting "communicator not found".There was only a retry and cancel option and no option for 'switch communicator".Powering off communicator and handset and powering back on equipment and retrying several times to get into the dbs therapy app were unsuccessful.The caller was unable to turn therapy back on.Email was sent to repair to send replacement communicator.Pss redirected patient to hcp regarding return of symptoms.

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.

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 was received.It was reported that the patient received the replacement communicator.The caller needed assistance connecting the replacement communicator to the handset and to link the ins to the handset as it didn't work the first time he tried it.Technical services was able to walk the caller through all the steps to pair the communicator to the handset and link the ins to the handset.The caller was able to see that therapy was off and got therapy turned back on, check battery levels of communicator, handset and ins today.Caller was really happy to have this completed and working for his wife today.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 13621147
• MDR Text Key: 296582708
• Report Number: 3004209178-2022-02586
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• Date Device Manufactured: 12/07/2018
• 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: 70 YR
• Patient Sex: Female