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

Model Number 37612

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)

Patient Problems Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: wr9200, serial# (b)(4), 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

Information was received from a manufacturer representative (rep) regarding an external device.The caller reported that the patient told them they were having difficulty maintaining a connection between the recharger and their implantable neurostimulator (ins)s.The patient disconnected before the healthcare it agent could transfer them to patient services, so agent called the patient using 'phone 2' phone number.The patient was using a wireless recharger (wr) and they had it in the drape.The patient said they have had difficulty maintaining a connection between the wr and both inss since implant date, and that they have called patient services before about this issue.The patient mentioned that they have had the wr replaced twice, but they continued to have difficulty maintaining a connection between the wr and inss.During the call, the wr made a connection with the right ins but then the wr started beeping shortly after that.Agent reviewed proper positioning of the wr, so the patient repositioned the wr and it was able to maintain an excellent connection (per the recharger app), and it was 75% charged.Therapy was on for the right ins.Agent had the patient charge the left ins, but they were unable to maintain a connection with it.The wr would connect to the left ins initially, but it could not maintain a connection for longer than a few seconds.This persisted even after the patient repositioned the wr.Agent asked the patient if they had any concerns regarding the pocket site for the left ins, and the patient said "it's raised a little bit," "feels like a band-aid," and "feels like something is around it." agent asked the patient if it felt like the left ins was titled, but they couldn't tell.The patient mentioned that a rep named (b)(6) (last name asked, unk) was aware of the issue, but the patient could not remember when the rep was notified.The patient said they had an appointment with their healthcare provider (hcp) and the rep, and the wr seemed to maintain a better connection then than it does now.The patient could not remember the date of that appointment.The patient said the connectivity issue has gotten progressively worse since that appointment.The patient said they tried using the wr without the drape, but that made it difficult to hold the wr in place.The patient was redirected to their healthcare provider to further address the issue.No symptoms reported.

Event Description

Additional information was received from the manufacturer representative (rep) that the patient reported that they often fall asleep while recharging.The rep instructed the patient to keep continuous contact with the charger and the battery during their recharging sessions and to keep the antenna over the battery at all times.At this time, the issue appeared to be resolved.However, the patient was encouraged to call the manufacturer representative or patient services if the problem persisted.The information was obtained and confirmed with the patient via a telephone call.

Manufacturer Narrative

Continuation of d10: product id wr9200 lot# 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 received from the consumer reported they spoke with the manufacturer¿s representative (rep) about ways to improve recharge duration like repositioning the wireless recharger, but it didn¿t help.The consumer noted today seeing a 1402 error code came up on the handset when they tried to enter the wireless recharger app while charging the implant and the wr light turned red.During the call the wr was powered on and there was no red light and was performing normally and connected but disconnected shortly after even after multiple attempts of repositioning the wr over the ins didn't resolve the issue.The consumer also mentioned pt since may their implant battery seemed to deplete quicker than before, and they didn¿t know why, but did mention they went from lower settings that didn¿t allow them to move, so they were increased, but this wasn¿t since the issue of the battery draining faster.

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: 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: 15958895
• MDR Text Key: 308073900
• Report Number: 3004209178-2022-16261
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/20/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male