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

Model Number 37612

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Failure to Power Up (1476); Operating System Becomes Nonfunctional (2996)

Patient Problems Dysphasia (2195); Discomfort (2330); Insufficient Information (4580)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Section d10 references: product id 37751 lot# serial# (b)(6), product type: recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 37751, 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

The consumer stated that when they were going to charge the implantable neurostimulator (ins) on thursday the recharger started beeping and the screen of the recharger went blank.There is no damage to the desktop charger (dtc) and there is a green light on.The caller stated stated that due to not charging the ins is turned off and they are having a return of symptom's.The caller stated that they cannot speak clearly and their handwriting is not legible when the ins is turned off.Pss had the caller confirm that the ins is turned off with the patient programmer.Pss had the caller attempt to reset the 37751, but the caller stated that the screen would still not come on.The caller stated that they are uncomfortable , and without the ins being on they have to deal with horrible intense dystonia symptoms.Due to the nature of the call , pss sent an email to repair to replace the 37751.The caller stated they will call ps back tomorrow to request the tracking information for the package.The caller stated that they have had the dtc replaced before.Additional information received from the consumer reported the implant turned off because the recharger wouldn¿t turn on.The consumer tried to reset their recharger, but it wouldn¿t charge so they received a new one which resolved the issue.

Manufacturer Narrative

Analysis of the recharger (s/n (b)(6)) found the complaint was unverified 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.

• 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: 18873102
• MDR Text Key: 337688785
• Report Number: 3004209178-2024-06726
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 03/10/2015
• 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: 59 YR
• Patient Sex: Female