MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Delayed Charge Time (2586); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 09/21/2021

Event Type  malfunction  

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

It was reported that the patient's device turned off and they did not know how the device turned off, and the patient remote would not connect to the implantable neurostimulator (ins).The call agent had the caller connect the patient remote to the ins and it connected without issue.The caller did not know that the patient was using the antenna, so once the antenna was placed over the ins there was no problem with the connection to the remote.The patient's caretaker reported that the ins has turned itself off 2-4 times in the past year.The patient falls when the ins turns off and they are concerned that the patient may die as a result.The caller indicated that at the time of the last physician visit the patient wasn't able to get the recharger to connect well for charging.The caller indicated that they provided adhesive patches for the patient to use.The caller stated that belts have been available in the past and made a general statement that the recharging belts do not work particularly well and they prefer to use adhesive patches.The patient reported that sometimes they charge the ins for four hours.The patient reported that they do not think the issue is related to charging but the ins is "a low quality battery".The hcp has considered replacing the ins with the patient.The patient stated that they don't have the same issues with the other manufacturer's ins and they want to either have a primary cell ins placed or the other manufacturer's rechargeable ins.The issue was not resolved through troubleshooting.The hcp will follow-up with the patient.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 15496410
• MDR Text Key: 302562137
• Report Number: 3004209178-2022-12483
• Device Sequence Number: 1
• Product Code: MHY
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Date Device Manufactured: 09/03/2010
• 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: 51 YR
• Patient Sex: Male