MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for essential tremor

Model Number 37601

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Communication or Transmission Problem (2896); Connection Problem (2900)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 37092, serial/lot #: unknown, ubd: , udi#:.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient programmer won't turn on with new batteries.A new programmer was sent.No symptoms were reported.Additional information was received from the consumer on (b)(6) 2021 stating that the issue resolved with the replacement and the screen is coming on now.During the call, they clarified that the original issue was misunderstood.The initial issue was poor communication.The screen came on but the patient could not see if the implantable neurostimulator (ins) was on.The new programmer screen does come on but still does not appear to connect to the ins.They noticed damaged on the antenna cable.It was reviewed how the patient can use the programmer alone to connect while waiting for the antenna.A replacement programmer antenna was sent.

Manufacturer Narrative

Continuation of d10: product id 37092, lot#/serial# unknown, product type multiple therapy product.Product id 37642, lot#/serial# (b)(6), product type programmer, patient.H3.Analysis was performed on [product id 37642, lot#/serial# (b)(6)] analysis found that the complaint was unverified.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 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 essential tremor
• 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: 11874726
• MDR Text Key: 252330724
• Report Number: 3004209178-2021-08242
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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
• Patient Age: 77 YR
• Patient Sex: Male