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

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Scar Tissue (2060); Neck Stiffness (2434); Paresthesia (4421); Insufficient Information (4580)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.The main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4), ubd: 09-mar-2024.Product id: 3389s-40, serial/lot #: (b)(4), ubd: 09-mar-2024.Product id: 3708660, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient says for about a week she¿s been noticing buzzing in her head and tingling face/jaw periodically.Started out 1 time per day and now is happening 3-4 times per day.There have been no reported falls and no changes to therapy settings.Troubleshooting includes patient is going to try lowering her settings to see if it resolves.Also, will try and shut therapy off for a day and see if it occurs with stimulation off.The issue was not resolved.Additional information was received.It was reported that the buzzing sensation occurs when the lead/extension connection is pressed on the head.All impedances were in normal range.The battery site was also tight for the patient.The patient was going to see the neurosurgeon to have the tension on the implant fixed.No surgery date scheduled yet.There doesn't appear to be an issue with hardware, just that there was too much tension and some coiled extension wire needs to be given so it's not so tightly implanted.The issue has not yet resolved pending the surgery.Additional information was received.It was reported that surgery hasn't been scheduled yet.Everything is tunneled to the patient's right side and implantable neurostimulator in right side of chest.Everything is pulling and tight.The battery wasn't left with enough slack and has scarred down and was tight for the patient.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 13862094
• MDR Text Key: 290166015
• Report Number: 3004209178-2022-03613
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2022
• Date Device Manufactured: 11/07/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female