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); No Device Output (1435); Use of Device Problem (1670); Battery Problem (2885); Charging Problem (2892); Operating System Becomes Nonfunctional (2996)

Patient Problems Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Patient representative wants to make sure  implantable neurostimulator (ins) is on.Caller stated patient saw neurologist in september and ins was off.Neurologist turned ins back on.Caller stated the past 2-3 times patient has seen dr the ins has been off.Caller mentioned sometimes if the ins is off the ins charges fast.Caller states the assisted living patient is at is very good at keeping patient charged.Caller states years ago patients charge level went down to nothing, caller states it was because the recharger antenna went bad, caller ordered the cord and it got lost in transit.Patient rep is not sure why lately the ins/ therapy goes off.Caller will call back when with patient.  patient rep stated over the weekend programmer shows a screen like it is trying to connect, programmer would show the screen with arrows pointing.Patient services (pss) is unsure what screen patient rep is describing and is unable to do troubleshooting due to caller not being with patient.Caller thinks it may be an issue with the programmer antenna but is unsure.Caller stated about a year or two ago programmer worked fine without antenna.Pss reviewed it will help if caller can be there with patient to do troubleshooting.No symptoms reported.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.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

D10: product id: 37642, serial# (b)(6), product type: programmer, patient.Product id: 37651, serial# (b)(6), product type: recharger.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 representative as they called back and mentioned having a conversation with patient services (pss) yesterday regarding them trying to figure out why they could not get the ins to turn on.The caller noted that they think the ins is off because the patient has been having a hard time moving.The caller was told to call back when they were with the patient and equipment to check the ins charge level.This morning, the caller said the recharger became unresponsive, was beeping, and the display was blank after the patient dropped the recharger.The caller said the patient dropped the recharger because of their parkinson's.Agent had the caller reset the recharger, but the issue persisted.The caller tried syncing the patient programmer with the ins, but they kept getting the poor communication screen (with and without the antenna).The caller put new aaa batteries in the patient programmer, but they continued to get the poor communication screen.The caller said the patient's ins was last charged over the weekend, at which time it was well over 50% charged.The issue was not resolved.A replacement recharger and patient programmer were sent.The caller repeated information regarding how the recharger antenna has been replaced in the past, and how their ins was off the past few times the patient checked in with their parkinson's doctor.Additional information was received from the patient representative as they called back stating they received the replacement recharger and patient programmer (pp).Caller confirmed that they were able to begin charging the patient's ins.Caller stated the ins was completely discharged when they started charging it, so therapy was off as a result.The caller mentioned that the patient was shaking so bad due to therapy being off, which made it difficult for them to keep the recharger antenna positioned over the ins as they charged it.The caller said they spent 2 hours charging the ins with the patient and it "maybe got up to 10%." the caller understood that the ins needs to be at least 25% charged before therapy can be turned on with the pp.The caller requested a recharging shoulder holster to help keep the recharger antenna in position over the ins.The caller mentioned that the patient used to have a recharging shoulder holster, but they must have lost it because they didn't know where it was.A recharger holster was sent.

Event Description

Additional information received from the consumer reported the cause of the device turning off was not keeping the battery charged to 25% or more.The consumer charged the battery to 60% and turned it back on.

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: 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: 16014437
• MDR Text Key: 307999099
• Report Number: 3004209178-2022-16679
• Device Sequence Number: 1
• Product Code: MHY
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2023
• Date Device Manufactured: 09/14/2015
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 95 KG