MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION COMMUNICATOR FOR PRECEPT NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Communicator for medtronic precept ins crashed and will not communicate with patient programmer or implanted neuro stimulator.Medtronic representative said this has happened before and is sending replacement by overnight express courier.My wife, who has parkinson's, is virtually catatonic because she cannot change ins settings to adjust therapy.Communicator was troublesome from time of first use following implant last month.Fda safety report id# (b)(4).

• Brand Name: COMMUNICATOR FOR PRECEPT NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15515527
• MDR Text Key: 301023495
• Report Number: MW5112337
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2022
• Patient Sequence Number: 1
• Treatment: AMANTADYNE; PRECEPT INS; RYTARY; VITAMIN C
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White