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); Battery Problem (2885); Connection Problem (2900)

Patient Problems Dysphagia/ Odynophagia (1815); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Section d10 references: product id 37791, product type recharger product id 37761, serial# (b)(6), product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6).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

Patient representative reported recharger would not charge the implant because it only shows the reposition antenna screen when trying to charge implant.No physical damage seen to recharger antenna.During call, patient services had patient rep check equipment as recharger wasn't showing that it was plugged into desktop charger (dtc) when it was.Patient rep saw that the desktop charger cord was damaged.Rep said the issues (damaged dtc cord and reposition antenna screen when trying to charge) started at the same time.An email was sent to repair to replace the desktop charger and recharger antenna.No symptoms were reported.Additional information received from the consumer reported they hadn¿t received the replacement recharger yet, and the patient was in the hospital.The neurostimulator was depleted and the patient was having difficulty swallowing.Later that day the patient received the replacement desktop charger which resolved the issue of the recharger not charging.The patient was able to charge the implant with good coupling, but therapy was turned off and they didn¿t have any external equipment to turn it back on.The process was started to get a patient programmer for the patient otherwise they were instructed to meet with their physician to have them turn therapy back on after the implant was charged.

Event Description

Additional information received from the healthcare provider (hcp) reported the patient was in the emergency room for influenza not related to their dbs device or therapy.The patient as in the emergency room for 7 hours and discharged.The desktop charger as replaced at an appointment on (b)(6) 2024 and they were able to get the dbs functional by the end of the appointment as the desktop charger was used to charge the recharger and then charge the implant.The patient had not had any issues with the device since the last appointment on february 16th.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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.

Manufacturer Narrative

Analysis of the desktop charger (s/n (b)(6)) found the cord was frayed 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: 18854628
• MDR Text Key: 337072254
• Report Number: 3004209178-2024-06459
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/05/2024; 03/18/2024
• Supplement Dates FDA Received: 03/11/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2014
• 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 Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male