MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC STIMLOC ANCHORING SYSTEM; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  Injury  

Event Description

Patient (b)(6) had bilateral gpi dbs surgery on (b)(6) 2021 for treatment of longstanding severe cervical dystonia and was discharged to home on (b)(6) 2021 (2 days post operation).While reviewing the patient's 2 month postop ct scan on (b)(6) 2021, the study neurosurgeon noted the patient's left pallidal lead has migrated upward by 1 cm.This is a known clinical complication with the standard clinical device (the medtronic stimloc anchoring system), and the patient's severe head shaking may have also contributed to this occurrence.The patient will return on (b)(6) 2021 for a procedure to have the lead repositioned back to the intended target.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC STIMLOC ANCHORING SYSTEM
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION ; minneapolis MN
• MDR Report Key: 12648677
• MDR Text Key: 277182528
• Report Number: MW5104677
• Device Sequence Number: 1
• Product Code: MRU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 69