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

Model Number 37603

Device Problems Failure to Interrogate (1332); No Device Output (1435); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphasia (2195); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

Product id: 37092, serial#: unknown, product type: accessory.Product id: 37642, serial#: (b)(4), implanted: (b)(6) 2019, product type: programmer, patient.Other relevant device(s) are: product id: 37092, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's programmer will intermittently connect to the implant after multiple attempts, 3-4 times before the controller finally connects to the ins.Troubleshooting was not required.The issue was not resolved through troubleshooting.An email was sent to the repair department to replace the programmer.Additional information received from the consumer reported the replacement programmer didn¿t resolve the issue as they were seeing the poor communication screen even with the replacement.During the call the consumer saw poor communication with the antenna but was able to connect with the implant without the antenna.It was noted the consumer turned stimulation off at night and due to the issue, they had been unable to connect to the implant to turn stimulation on which made it hard for them to talk.During the call stimulation was turned back on successfully.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12033656
• MDR Text Key: 265889690
• Report Number: 3004209178-2021-09690
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2021

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: 07/14/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/21/2021
• Date Device Manufactured: 01/14/2019
• 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: 91 YR