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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429)

Patient Problems Bruise/Contusion (1754); Muscle Weakness (1967); Visual Impairment (2138); Malaise (2359); Ambulation Difficulties (2544)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id (b)(4) (serial: unknown); product type: 2201-mobile platform; implant date n/a; explant date n/a 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

The patient (pt) reason for call was for assistance checking to ensure that dbs therapy was on.Pt said they just got off the phone with manufacturer representative (rep) and rep showed pt how to check therapy but they weren't able to back out of the screen so the  rep had them power off the handset.Pt wanted assistance to make sure therapy was actually on and to be educated on how to exit current screen they were in.Dbs therapy app showed implant at 100% and therapy on.Ps emailed repair to send replacement handset to pt.Pt said they had thought their therapy was off today because they felt unwell and couldn't see or walk well, like their dbs therapy wasn't helping them at all.Pt said they felt the same way they did back in (b)(6) 2024 when the implant went off without them knowing (details reported in rtg0548924).Pt said they fell on weds (b)(6) 2024) and they fell really hard forward in a parking lot and may have hit their chest, pt said they think they may have hit their face because they had some bruising on their nose.During call patient increased therapy settings (pt said their healthcare provider (hcp) had given them permission to increase settings up a couple notches if needed).Pt said they could already feel the therapy working and felt a little better.Pt said they didn't want to increase too high because they didn't want to feel badly like they have in the past when they increased therapy too high.Patient services (pss) redirected pt to hcp regarding symptoms/ to make hcp aware of fall.Pt said they had talked to managing hcp today.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the consumer reported they didn¿t know what led to therapy being off and their fall.The issue was resolved as the patient received another external device and were not closing the application.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the consumer reported they noticed a change in their performance including walking, feeling weak, not being able to keep their eyes open which was when they noticed therapy was off.They received a new handset which resolved the issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18887487
• MDR Text Key: 337564302
• Report Number: 3004209178-2024-06892
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 02/10/2021
• 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
• Treatment: SEE H11.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG