MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC DBS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Device Problem Use of Device Problem (1670)

Patient Problems Emotional Changes (1831); Headache (1880); Vomiting (2144); Movement Disorder (4412)

Event Date 01/16/2022

Event Type  Injury  

Event Description

The patient had a deep brain stimulator (dbs) in place due to a previous diagnosis of parkinson¿s disease.The dbs device was a medtronic device, with the number '37642' on the front.The patient attended the accident and emergency department in london due to an acute change in his symptoms, which was later found to be due to an error in the dbs.The patient presented with vomiting, headache and widespread involuntary movements, he was also distressed at the time.All other causes were excluded following blood tests and a ct brain scan and the patient was transferred to a specialist center.His symptoms only resolved when the clinical programmer was able to reset the dbs settings, the underlying cause for the error in the dbs setting remains unclear.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC DBS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 14644654
• MDR Text Key: 293833377
• Report Number: MW5110221
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2022

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White