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

Model Number 37612

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37612; serial# (b)(6) implanted: (b)(6) 2022; product type implantable neurostim ulator product id wr9200 serial# (b)(6); product type recharger product id tm90d0 lot# serial# (b)(6); product type accessory 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 patient regarding the wireless recharger (wr) and implantable neurostimulator (ins) not charging.The reason for call was patient stated for about a week, patient has had a huge difficulty finding the place where the recharger connects to the ins and then disconnects or sometimes it will connect for an hour and then disconnect.Patient stated she has always had a hard time connecting both left and right ins and recharger since implant because the ins's don't not lay flat.Patient service specialist asked patient if she has had any hard falls and patient states no.The circumstances that led to the reported issue were asked but unknown.During the call, wireless recharger was reset in and out of dock.Patient was able to connect recharger with implant on the left side.But when trying the right side, the recharger connection to ins did not stay connected.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider (hcp) to further address the issue.Also issue with an external device, communicator, at first tm90 was not connecting and handset showing no device found, communicator not found, but after patient continued to click on retry the tm90 issue was resolved.Patients left ins was showing 25% charges and left ins 0% charged but therapy on.The following troubleshooting steps were performed: reset the wr.Additional troubleshooting information: patient wondering what to do if ins depletes.Patient is not sure if she should go to the er or call her managing healthcare provider.Patient will call her healthcare provider and see what she needs to do.Patient is having ins's replaced on june 8th with non- rechargeable ins.An email was sent to the repair department to replace the wireless recharger.No symptoms 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.

Event Description

Additional information received from the consumer reported the implant was going to be replaced due to improper placement of the generator.Once the recharger was replaced the charging issue was resolved.

• 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: 17106459
• MDR Text Key: 316952155
• Report Number: 3004209178-2023-10355
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/20/2023
• Date Device Manufactured: 04/27/2022
• 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 H10...."
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 56 KG