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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211)

Patient Problem Ambulation Difficulties (2544)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was during related call, caller wanted to provide the feedback that the patient's response to dbs was dramatic (improvement) they would not be alive if it weren't for dbs and they went from a non rechargeable to a rechargeable.Caller said they wanted to avoid what happened before when the ins battery died and patient (pt) could not move at all.Caller said this happened when the patient's first ins went off.Caller said they were told it would last from 5-7 years and went dead a year and a half.Caller said when they went to the doctor they were told they had 3 months left but 30 days later it turned off.Caller said the patient is in a wheelchair could not move their wheelchair on a wooden floor.Caller asked if there were other strategies patient services (pss) could provide to prevent loss of therapy.Redirected to their doctor or the doctor and the rep.

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.

• 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: 16717675
• MDR Text Key: 313072531
• Report Number: 3004209178-2023-04843
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• 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
• Report Date: 04/11/2023

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: 08/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/11/2023
• Date Device Manufactured: 03/10/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female