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

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Shaking/Tremors (2515); Ambulation Difficulties (2544); Peripheral Nervous Injury (4414); Paresthesia (4421)

Event Type  Injury  

Event Description

It was reported that their tremor was almost as bad as it was before they had a dbs.The patient added that they felt like they almost had "drop foot" on their right lower extremity.The patient defined "drop foot" as having paralysis of an extremity, specifically having their foot drop whenever they lie down.Agent asked if therapy had turned off, but the patient denied this and stated that they always keep therapy turned on.The patient stated that they initially reported this issue to a healthcare provider (hcp), at which time group a was active.After that, the patient had another appointment with a different hcp.At that appointment, the patient stated that the hcp tried groups c & d with stimulation set to 4.5 v, but the patient's tingling was worse.The hcp decreased stimulation to 3.5 v, but then the patient had difficulty with hand movement.As a result, the hcp changed to group b, increased stimulation to 5.0 v, and reduced pulse width to 80.After these changes were made, the hcp noticed the patient's tremor was better controlled and their gait was better.The patient stated that their hcp recommended staying on group b and continue current medication.The patient was concerned that stimulation was "maxed out" at 5.0, so agent asked if the current therapy settings were helping to manage their tremor.The patient responded, "it has helped me to the point of 5.0." agent did not understand what the patient meant by that; agent did not ask for further clarification due to the nature of the call.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

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 from the patient that circumstances that led to drop foot include change to device programming.The issue did not resolve, rehab assessment appointment on (b)(6) 2022.

• 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: 13903939
• MDR Text Key: 287914533
• Report Number: 3004209178-2022-03787
• Device Sequence Number: 1
• Product Code: PJS
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2022
• Date Device Manufactured: 05/14/2018
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 98 KG