MAUDE Adverse Event Report: MEDTRONIC, INC ACTIVA DBS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 11/01/2020

Event Type  Injury  

Event Description

Patient began to experience a condition called "tethering" within approximately 2 months of implantation of medtronic activa dbs system.System is intended to help alleviate some symptoms of parkinson's disease, primarily tremors, through direct brain stimulation.Heavy scar tissue formation began along wire leads from ipg (in patient generator) to connector located on side of patient's skull.These wire leads ran sub-dermally from the ipg, over the clavicle, and up patient's neck on left hand side.Scar tissue formation caused increasing tension on wires, and pulling of wires on ipg unit and connector when the patient moved his head.The condition became increasingly painful and debilitating, until decision was made to have surgery to excise scar tissue and relieve pressure on wiring and ipg.Surgery initially helped with pain, but rapid re-accumulation of scar tissue soon lead to recurrence of pain and tension.This time, the decision was made to permanently remove the ipg and wiring up to the connector.The operation was performed, but ironically, the established tunnel of scar tissue around the wiring continued to build even after the equipment was removed.Though reduced in intensity, the pain and pulling of the scar tissue when the patient moves head and neck continues.It appears that additional surgery will be required to deal with problem of scar tissue, even after permanent explantation of medical equipment.Fda safety report id #(b)(4).

• Brand Name: ACTIVA DBS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC, INC
• MDR Report Key: 11776519
• MDR Text Key: 249699968
• Report Number: MW5101156
• Device Sequence Number: 1
• Product Code: NHL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/01/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 57 YR
• Patient Weight: 93