MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION LEADS AND EXTENSION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Balance Problems (4401)

Event Date 09/28/2023

Event Type  Injury  

Event Description

We were informed on (b)(6) 2023 about an explant of medtronic deep brain stimulation (dbs) leads and extensions on (b)(6) 2023 due to balance issues, trouble speaking, and ineffective tremor control.The surgeon reports that these symptoms were due to misplaced and malfunctioning medtronic dbs leads.These are not devices manufactured by (b)(6).The explant occurred at (b)(6) hospital in (b)(6) with dr.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEEP BRAIN STIMULATION LEADS AND EXTENSION
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 18032399
• MDR Text Key: 327181841
• Report Number: MW5147434
• 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: Other
• Type of Report: Initial
• Report Date: 10/02/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2023
• Patient Sequence Number: 1