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); Unintended Collision (1429); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Fall (1848)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that the patient has been having issues with left implant for about 2-3 months.Caller states right implant seems to be working fine.Patient service specialist (pss) asked if patient has had any falls and patient states she has had a couple hard falls.Patient states the left implant is not producing anything and therapy is off because patient does not have enough charge in the implant.Patient is able to charge right implant fine.Patient reports recharger is beeping.Patient has been trying to charge for a couple hours and is not able to get the implant to charge past 25%.Patient was able to connect to implant with excellent connection and therapy was off.Although able to charge, the implantable neurostimulator (ins) and recharger kept disconnecting and patient had to continue to repositioning the recharger.Recharger was reset but that did not resolve the problem.Pss reviewed with patients son , patient can continue recharging and then use dbs therapy app to turn therapy back on.Pss redirected to healthcare provider (hcp) due to issue with left ins.

Manufacturer Narrative

Date is approximate.Year is confirmed valid.Continuation of d10: product id 37612 (b)(6); product type: 0197-implantable neurostimulator; implant date (b)(6) 2018; product id neu recharger acc (serial: unknown); 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.

• 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: 18573734
• MDR Text Key: 334366636
• Report Number: 3004209178-2024-01973
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2024

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: 09/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/24/2024
• Date Device Manufactured: 10/25/2015
• 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: 87 YR
• Patient Sex: Female