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

Model Number 37612

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

Patient Problem Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins) and external device.The caller reported that the patient's involuntary movements became a lot more noticeable and they were becoming somewhat immobile.The caller stated that the patient's managing healthcare provider (hcp) requested that the patient be hospitalized due to their symptoms, so the patient was in the hospital at the time of the call.The caller added that the recharger was not properly charging the patient's ins, and it was taking entirely too long to get the ins fully charged.During the call, agent had the caller start a recharging session of the patient's ins and the caller stated that the ins was turned on, the final quarter of the ins was charging, and all of the coupling bars were empty.Agent reviewed that the ins will charge slowly when the coupling bars are empty.Agent had the caller reposition the antenna and rotate the antenna dial, and they eventually got all 8 coupling bars to fill in.Agent reviewed that the ins will charge more efficiently if they can maintain good coupling.The caller mentioned that the patient was using adhesive discs, but the adhesive was not staying on the ins.The caller added that the patient kept moving a lot, which caused the antenna to slide off the ins.Agent reviewed that the recharging shoulder holster (3550-55) is an accessory that may help keep the antenna locked in position over the ins.An email was sent to the repair department to request a recharging shoulder holster.

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.Continuation of d10: product id 97754 (serial: (b)(6)); product type: 0213-recharger; implant date n/a; explant date n/a 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 received from the consumer reported the patient was in the hospital and it took them a long time to get good coupling.The patient did receive the recharging shoulder holster, but they didn¿t like it and refused to use it.The patient did not want to change to a wireless recharger.

• 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: 17885413
• MDR Text Key: 325078020
• Report Number: 3004209178-2023-17131
• Device Sequence Number: 1
• Product Code: MHY
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Date Device Manufactured: 01/12/2017
• 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 Outcome(s): Hospitalization
• Patient Sex: Male