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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Dysphasia (2195); Discomfort (2330); Shaking/Tremors (2515); Ambulation Difficulties (2544); Electric Shock (2554); Balance Problems (4401); Speech Disorder (4415); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported by the patient that their therapy affected their balance and speech.The patient noted that the balance and speech symptoms went away when therapy was off, but their hands, head, and voice would shake (from essential tremor).The patient stated that they constantly fell because of their terrible balance.In the last month, the patient said they fell twice; one fall resulted in a broken rib, and the other one resulted in a torn rotator cuff.Regarding their speech, the patient said they have to work really hard at how they talk because it sounds like they are a little drunk sometimes.The patient mentioned that 2-3 years ago, they saw dr.(b)(6) have the therapy settings adjusted when the dr."maxed out" the settings.When they initially got the dbs, the patient mentioned that they turned therapy off at night and turned it back on in the morning.However, they felt like a rush of electricity was going through their body when they turned therapy back on, which they described as awful and uncomfortable.As a result, for the last 2-3 years, the patient decided to keep therapy turned on at all times.The patient also noticed that their legs (balance) and speech would get even worse whenever they turned therapy back on, but they said they got used to that.Over the last couple of months, the patient noticed that their ins battery seemed not holding a charge, noting that therapy has turned off several times due to the ins battery level getting too low.The patient mentioned that one of these times, they were at work and could feel the therapy turn off.The patient confirmed that they were able to charge their ins and turn therapy back on each time that happened.Yesterday, the patient noticed that their patient programmer said their ins battery level was low and mentioned that it took 5 hours to charge their ins to 75% with good coupling (all eight coupling bars filled in).The agent reviewed that the charge duration was appropriate considering the low ins battery level when the patient started charging it.The patient mentioned that they otherwise charge their ins for 30-45 minutes twice a week.The agent reviewed that the recharging equipment was working correctly and redirected the patient to their healthcare provider (hcp) to address the issue further.The patient stated that they have an appointment with dr.(b)(6) on (b)(6) 2022.

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.

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 consumer who reported that the steps taken to resolve the balance and speech issues and the rush of electricity is they are leaving the device on full-time.It was stated the device is not holding a charge and the patient has an appointment with their hcp.

• 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: 14952621
• MDR Text Key: 295477260
• Report Number: 3004209178-2022-08606
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2022
• Date Device Manufactured: 06/21/2016
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 83 KG