MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Headache (1880); Malaise (2359); Neck Pain (2433); Shaking/Tremors (2515)

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported when they tried to charge the left implantable neurostimulator (ins), it showed that the ins was at 100% (screen with the water droplets).They charged every day and it was strange that the ins showed 100% today.They stated that since they have two inss, they tried connecting both of their implantable neurostimulator rechargers (insrs) to the insr on the right side and both showed normal charging screens.Then they would turn the insrs off and tried to connect with the left ins and they both consistently showed that the ins was full.They stated that the patient programmer (pp) was with their wife and the wife was not home.They connected once again to the ins with the insr and confirmed that they were able to see that the ins wason.They mentioned that the left ins has "always been somewhat hard to find when charging", but they always manages to find it.They were worried that since they are doing physical therapy, that a wire (lead) came loose because they do not feel well today and have been dealing with shaking, neckaches, and headaches.They have always dealt with some neck and head pain so they are not sure if they are related or not.They were able to confirm that it was just today that the ins was not depleting.It was reviewed that the external equipment appears to be working as intended but the patient should speak with the healthcare provider (hcp) regarding symptoms and having the ins checked if it continued to show 100%.Refer to manufacturer report #3004209178-2020-21311 for related device.

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 they called the manufacturer and their healthcare provider (hcp) related to the issue.They made an appointment to check on symptoms and if they could detect anything wrong with the device; it was not confirmed to be loose.The consumer stated the ¿usual symptoms¿ didn¿t seem to be worse and the hcp didn¿t find any problems with the device.The particular implantable neurostimulator (ins) (the consumer had 2) is the one that was resurfacing years ago and had to be repositioned deeper.It was sometimes hard for the charger to make contact.The consumer was ¿baffled and worried¿ why the device was always saying 100% for days even before they started charging.The consumer stated the issue was resolved, they just had to press hard to make a good connection.The consumer stated the cause of the left implant showing 100% charged was some of the wires being ¿worn¿ or exposed¿ on the charging devices cord which was replaced by the manufacturer resolving the issue of the device always showing 100% charged.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10960095
• MDR Text Key: 220971163
• Report Number: 3004209178-2020-21312
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 86