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

Model Number 37601

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of the event (b)(6) 2018, is an estimate if information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2018: (b)(4): information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that patient had been having issues with their device, patient stated that when they lay down, they get shocks across the chest and to the fingers.Patient stated that shocks happen every 5-20 seconds, further mentioning that most of the time the shocks are every 5 seconds.The shocks are more prominent when patient is laying down.It was noted that the shocks are most pronounced when patient lays on their right side, patient noted that they feel less shocks when patient is on their left side, and they feel shocks once in a while when she is on her back.Patient reported that it had been going on for about a month.Patient stated that impedance checks have been done and the impedances checked out wonderful.The patient's device has been checked when patient is sitting and laying down.Patient mentioned that they had lowered settings three times, patient had not tried turning stimulation completely off and doesn't want to due to symptom return.There was no fall/trauma that could be related to the issue that was reported.Patient stated that about a month before the shocks started, patient was riding a jeep and got jostled.Patient started doing yoga then she stopped doing yoga, but it didn't make a difference in the shocks.Patient does not feel the shocks while doing yoga.Patient stated that in june the active electrode was changed, which helped her therapy be more targeted.Patient noted that they are in a deep brain stimulation support group and several people said they had the same thing.Patient noted that some mentioned polarity change.Patient further mentioned that she knows what the stimulation feels like in their brain.Patient stated that they had not had any surgeries this year.Patient stated that she knows the programming can be trial and error, and patient did programming changes for 5 years.Patient was redirected to follow-up with the health care professional (hcp).No further patient complications were reported/anticipated as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.Patient stated that the doctor feels the shocks across the chest may be the therapy side effects, but the doctor has no theory as to why the patient feels shocks in their shocks.Patient stated that no actions have been taken to resolve the issue, however the patient figured that the more water patient drinks during the day, the less severe the shocks are.Patient also noted that they feel shocks in the head radiating.Patient was told not to lay down if it was too intense.The issue was not resolved yet.

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.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.

• 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: 8064502
• MDR Text Key: 128591386
• Report Number: 3004209178-2018-25311
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 61