MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER

Model Number 37601

Device Problems Energy Output Problem (1431); Vibration (1674); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328)

Event Date 09/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product id 37601 lot# serial# (b)(4) implanted: (b)(6)2019 explanted: product type implantable neurostimulator if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that after speaking with the patient and physician it was said that the patient needed adjustments in stimulation and there was not a total loss of therapy.There was also no por.The symptom of the ins shaking in their chest seemed to be due to loud noise from the speaker causing their ins to vibrate.When they moved away after 1 min they felt the feeling of being uncomfortable, having anxiety, and vibrating ins stop.The patient was having therapy adjustments to resolve the issue.There were no further complications reported.

Manufacturer Narrative

Other applicable components are: product id: 37601, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for obsessive compulsive disorder, movement disorders.It was reported that the caller stated the patient emailed the rep and was questioning whether their therapy was still working for them.The caller quickly read through the email and reported therapy helped about 80% before but within the last couple of weeks things were ¿horrifying,¿ and they felt like they can¿t escape, were trapped inside their head and reported a sudden loss of therapy.The caller stated the patient had read literature that something like that could happen with therapy.The caller emailed back to ensure ins¿ were on and inquired about using lcc as they were going to be calling the patient back today.It was recommended by technical services not to use lcc and just to interrogate to ensure ins¿ were on.Additional information was received from the rep stating that the ins¿ showed on and ok and correct therapy settings.The caller reported the patient stated they were at a concert where they were 10 feet away from about 30 speakers and felt severely anxious, uncomfortable and that the ins¿ were vibrating in their chest, but once the patient moved away from the speakers, they felt fine and symptoms went away.The patient mentioned that they had been having more ocd tendencies even prior to the concert and issues may have been going on for longer than the patient thought, and it all manifested itself into thinking the device wasn¿t working as well.The caller emailed the doctor and let them know that the patient may need their therapy to be adjusted.Technical services discussed potential that ins¿ incurred a por during the concert which would have momentarily stopped therapy but then been resolved.Technical services suggested to have hcp watch for por and alert if patient went into office for interrogation.There were no further complications reported.

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.

• Brand Name: ACTIVA
• Type of Device: DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9182132
• MDR Text Key: 166700230
• Report Number: 3004209178-2019-19299
• Device Sequence Number: 1
• Product Code: OLM
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• Combination Product (y/n): N
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR