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

Model Number 37601

Device Problems Failure to Interrogate (1332); Mechanical Problem (1384); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37642 lot# serial# (b)(6) product type programmer, patient.Section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: (b)(6), ubd: , udi#: (b)(4).This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 h3: analysis of the 37642 programmer (serial number (b)(6)) revealed that there was no anomalies.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

It was reported that the 006 call your doctor code came up on the patient programmer yesterday.Patient (pt) said they weren't able to get the patient programmer to power on unless they took the aaa batteries out and put them back in.Pt said that the sync button seemed to be stuck because when they pressed it the check mark (sync screen) stayed the same and didn't progress to connecting with ins.Pt took aaa batteries out of patient programmer and pressed and released all keys on the patient programmer but pt still wasn't able to power on patient programmer like normal with on/off button, patient programmer came back on once aaa batteries were taken out and put back in.Pt said that the aaa batteries weren't lasting as long as normal and said they put new batteries in about a month ago and they were already decreased.Pt said they had been traveling and the patient programmer had been through air port x-ray security and could've been banged up.The issue was not resolved.An email was sent to the repair department to replace the patient programmer.No symptoms were reported.Additional information was received from the patient that confirmed they received the replacement patient programmer (pp).The patient mentioned that the replacement pp resolved the issue that was reported in (b)(4), and that they are returning the pp that was not working correctly.

• 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: 18628424
• MDR Text Key: 334374908
• Report Number: 3004209178-2024-03224
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• 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: Male